NDC Code 0093-4161-73 - Amoxicillin Trihydrate

NDC Code(s) : 0093-2263-01, 0093-2264-01, 0093-4160-76, 0093-4160-78, 0093-4160-73, 0093-4155-79, 0093-4155-73, 0093-4155-80, 0093-4161-76, 0093-4161-78, 0093-4161-73, 0093-2267-01, 0093-2268-01, 0093-3107-01, 0093-3107-05, 0093-3109-53, 0093-3109-06, 0093-3109-01, 0093-3109-05
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmoxicillinAmoxicillin TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-2263
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	500 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)

Product Characteristics
Color	white (off-white)	Score	no score
Shape	OVAL (capsule-shaped)	Size	17 mm
Flavor		Imprint Code	93;2263
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-2263-01	100 in 1 BOTTLE Type 0: Not a Combination Product	21/11/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065056	11/21/2000

AmoxicillinAmoxicillin TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-2264
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	875 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)

Product Characteristics
Color	white (off-white)	Score	2 pieces
Shape	OVAL (capsule-shaped)	Size	21 mm
Flavor		Imprint Code	93;2264
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-2264-01	100 in 1 BOTTLE Type 0: Not a Combination Product	26/09/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065056	09/26/2000

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-4160
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0093-4160-76	50 mL in 1 BOTTLE Type 0: Not a Combination Product	07/01/2003
2	NDC:0093-4160-78	75 mL in 1 BOTTLE Type 0: Not a Combination Product	07/01/2003
3	NDC:0093-4160-73	100 mL in 1 BOTTLE Type 0: Not a Combination Product	04/02/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065119	04/02/2003

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-4155
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	250 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40(UNII: WZB9127XOA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0093-4155-79	80 mL in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990
2	NDC:0093-4155-73	100 mL in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990
3	NDC:0093-4155-80	150 mL in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA061931	09/30/1990

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-4161
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	400 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0093-4161-76	50 mL in 1 BOTTLE Type 0: Not a Combination Product	07/01/2003
2	NDC:0093-4161-78	75 mL in 1 BOTTLE Type 0: Not a Combination Product	07/01/2003
3	NDC:0093-4161-73	100 mL in 1 BOTTLE Type 0: Not a Combination Product	26/02/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065119	02/26/2003

AmoxicillinAmoxicillin TABLET, CHEWABLE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-2267
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	125 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL (capsule-shaped)	Size	15 mm
Flavor	CHERRY	Imprint Code	93;2267
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-2267-01	100 in 1 BOTTLE Type 0: Not a Combination Product	10/01/1995

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064013	10/01/1995

AmoxicillinAmoxicillin TABLET, CHEWABLE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-2268
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	250 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)

Product Characteristics
Color	white (white to off-white)	Score	2 pieces
Shape	OVAL (capsule-shaped)	Size	19 mm
Flavor	CHERRY	Imprint Code	9;3;2268
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-2268-01	100 in 1 BOTTLE Type 0: Not a Combination Product	01/01/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064013	01/01/1993

AmoxicillinAmoxicillin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-3107
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	250 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2 ALUMINUM LAKE(UNII: 4AQJ3LG584)

Product Characteristics
Color	brown (caramel), brown (buff)	Score	no score
Shape	CAPSULE	Size	18 mm
Flavor		Imprint Code	TEVA;3107
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0093-3107-01	100 in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990
2	NDC:0093-3107-05	500 in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA061926	09/30/1990

AmoxicillinAmoxicillin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-3109
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	500 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)

Product Characteristics
Color	brown (buff)	Score	no score
Shape	CAPSULE	Size	22 mm
Flavor		Imprint Code	TEVA;3109
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0093-3109-53	50 in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990
2	NDC:0093-3109-06	60 in 1 BOTTLE Type 0: Not a Combination Product	15/12/2023
3	NDC:0093-3109-01	100 in 1 BOTTLE Type 0: Not a Combination Product	15/12/2023
4	NDC:0093-3109-05	500 in 1 BOTTLE Type 0: Not a Combination Product	30/09/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA061926	09/30/1990

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

NDC 0093-2263-01
Amoxicillin Tablets, USP
500 mg
AMOXICILLIN USP, 500 mg as the trihydrate
Rx only
100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0093-2264-01
Amoxicillin Tablets, USP
875 mg
AMOXICILLIN USP, 875 mg as the trihydrate
Rx only
100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0093-4160-73
Amoxicillin for Oral Suspension, USP
200 mg per 5 mL
When reconstituted, each 5 mL contains: AMOXICILLIN USP, 200 mg as the trihydrate
Rx only
100 mL (when reconstituted)

PRINCIPAL DISPLAY PANEL

NDC 0093-4155-73
Amoxicillin for Oral Suspension, USP
250 mg per 5 mL
When reconstituted, each 5 mL contains: AMOXICILLIN USP, 250 mg as the trihydrate
Rx only
100 mL (when reconstituted)

PRINCIPAL DISPLAY PANEL

NDC 0093-4161-73
Amoxicillin for Oral Suspension, USP
400 mg per 5 mL
When reconstituted, each 5 mL contains: AMOXICILLIN USP, 400 mg as the trihydrate
Rx only
100 mL (when reconstituted)

PRINCIPAL DISPLAY PANEL

NDC 0093-2267-01
Amoxicillin Tablets, USP
(Chewable)
125 mg
AMOXICILLIN USP, 125 mg as the trihydrate
Rx only
100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0093-2268-01
Amoxicillin Tablets, USP
(Chewable)
250 mg
AMOXICILLIN USP, 250 mg as the trihydrate
Rx only
100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0093-3107-05
Amoxicillin Capsules, USP
250 mg
Rx only
500 Capsules

PRINCIPAL DISPLAY PANEL

NDC 0093-3109-05
Amoxicillin Capsules, USP
500 mg
Rx only
500 Capsules

NDC 0093-4161-73
API & Excipient Details

Amoxicillin Trihydrate marketed by Teva Pharmaceuticals USA, Inc. under NDC Code 0093-4161-73

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0093-4161-73 API & Excipient Details

Amoxicillin Trihydrate marketed by Teva Pharmaceuticals USA, Inc. under NDC Code 0093-4161-73

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0093-4161-73
API & Excipient Details