NDC Code(s) : 0781-2020-31, 0781-2020-76, 0781-2020-01, 0781-2020-05, 0781-2613-31, 0781-2613-76, 0781-2613-01, 0781-2613-05, 0781-5060-20, 0781-5060-01, 0781-5061-20, 0781-5061-01, 0781-6039-58, 0781-6039-46, 0781-6039-55, 0781-6156-52, 0781-6156-57, 0781-6156-46, 0781-6041-58, 0781-6041-46, 0781-6041-55, 0781-6157-52, 0781-6157-57, 0781-6157-46
Packager : Sandoz Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmoxicillinAmoxicillin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
Product Characteristics
Color YELLOW (Opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code AMOX;250;GG;848
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2020-7612 in 1 PACKAGE 30/09/1994
1NDC:0781-2020-3130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0781-2020-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1994
3NDC:0781-2020-05500 in 1 BOTTLE Type 0: Not a Combination Product30/09/1994
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064076 09/30/1994
AmoxicillinAmoxicillin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2613
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
Product Characteristics
Color YELLOW (Opaque) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code AMOX;500;GG;849
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2613-7612 in 1 PACKAGE 30/09/1994
1NDC:0781-2613-3130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0781-2613-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1994
3NDC:0781-2613-05500 in 1 BOTTLE Type 0: Not a Combination Product30/09/1994
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064076 09/30/1994
AmoxicillinAmoxicillin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (slightly yellowish) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code GG;961;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-5060-2020 in 1 BOTTLE Type 0: Not a Combination Product13/07/2005
2NDC:0781-5060-01100 in 1 BOTTLE Type 0: Not a Combination Product13/07/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065228 07/13/2005 09/30/2015
AmoxicillinAmoxicillin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5061
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (slightly yellowish) Score 2 pieces
Shape OVAL Size 21 mm
Flavor Imprint Code GG;962;875
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-5061-2020 in 1 BOTTLE Type 0: Not a Combination Product13/07/2005
2NDC:0781-5061-01100 in 1 BOTTLE Type 0: Not a Combination Product13/07/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065228 07/13/2005
AmoxicillinAmoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6039
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-6039-5880 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
2NDC:0781-6039-46100 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
3NDC:0781-6039-55150 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065387 03/26/2007
AmoxicillinAmoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6156
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-6156-5250 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
2NDC:0781-6156-5775 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
3NDC:0781-6156-46100 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065378 03/26/2007
AmoxicillinAmoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6041
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-6041-5880 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
2NDC:0781-6041-46100 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
3NDC:0781-6041-55150 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065387 03/26/2007
AmoxicillinAmoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-6157-5250 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
2NDC:0781-6157-5775 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
3NDC:0781-6157-46100 mL in 1 BOTTLE Type 0: Not a Combination Product26/03/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065378 03/26/2007

LABELER - Sandoz Inc(005387188)

PRINCIPAL DISPLAY PANEL

amox-capsules-250mg

NDC 0781-2020-01

Amoxicillin

Capsules, USP

250 mg

Rx Only

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL

amox-capsules-500mg

NDC 0781-2613-01

Amoxicillin

Capsules, USP

500 mg

Rx Only

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL

amox-tablet-500mg

NDC 0781-5060-20

Amoxicillin

Tablets, USP

500 mg

Rx Only

20 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL

amox-tablet-875mg

NDC 0781-5061-20

Amoxicillin

Tablets, USP

875 mg

Rx Only

20 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL

os-125mg-5ml-label

NDC 0781-6039-58

Amoxicillin for

Oral Suspension, USP

125 mg/5 mL

Rx Only

When reconstituted, each 5 mL

(1 teaspoonful) will contain

amoxicillin trihydrate equivalent

to 125 mg amoxicillin.

80 mL

(when reconstituted)

SANDOZ

PRINCIPAL DISPLAY PANEL

os-200mg-5ml-label

NDC 0781-6156-52

Amoxicillin for

Oral Suspension, USP

200 mg/5 mL

Rx Only

When reconstituted, each 5 mL

(1 teaspoonful) will contain amoxicillin

trihydrate equivalent to 200 mg

amoxicillin.

50 mL (when reconstituted)

SANDOZ

PRINCIPAL DISPLAY PANEL

os-250mg-5ml-label

NDC 0781-6041-58

Amoxicillin for

Oral Suspension, USP

250 mg/5 mL

Rx Only

When reconstituted, each 5 mL

(1 teaspoonful) will contain

amoxicillin trihydrate equivalent

to 250 mg amoxicillin.

80 mL

(when reconstituted)

SANDOZ

PRINCIPAL DISPLAY PANEL

os-400mg-5ml-label

NDC 0781-6157-52

Amoxicillin for

Oral Suspension, USP

400 mg/5 mL

Rx Only

When reconstituted, each 5 mL

(1 teaspoonful) will contain amoxicillin

trihydrate equivalent to 400 mg

amoxicillin.

50 mL (when reconstituted)

SANDOZ