NDC Code(s) : 0781-1874-31, 0781-1831-20, 0781-1831-13, 0781-1831-01, 0781-1852-20, 0781-1852-13, 0781-1852-01, 0781-6102-46, 0781-6102-57, 0781-6102-52, 0781-6104-46, 0781-6104-57, 0781-6104-52, 0781-1619-66, 0781-1643-66
Packager : Sandoz Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1874
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID125 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CETYL ALCOHOL(UNII: 936JST6JCN)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule-shaped) Size 18 mm
Flavor Imprint Code GGN5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1874-3130 in 1 BOTTLE Type 0: Not a Combination Product23/08/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065189 08/23/2005
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1831
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID125 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CETYL ALCOHOL(UNII: 936JST6JCN)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 21 mm
Flavor Imprint Code GGN6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1831-2020 in 1 BOTTLE Type 0: Not a Combination Product15/03/2002
2NDC:0781-1831-13100 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product15/03/2002
3NDC:0781-1831-01100 in 1 BOTTLE Type 0: Not a Combination Product20/09/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065064 03/15/2002
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1852
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID125 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CETYL ALCOHOL(UNII: 936JST6JCN)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 22 mm
Flavor Imprint Code GGN7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1852-2020 in 1 BOTTLE Type 0: Not a Combination Product14/03/2002
2NDC:0781-1852-13100 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product14/03/2002
3NDC:0781-1852-01100 in 1 BOTTLE Type 0: Not a Combination Product20/09/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065063 03/14/2002
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6102
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID28.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MANNITOL(UNII: 3OWL53L36A)
ORANGE(UNII: 5EVU04N5QU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-6102-46100 mL in 1 BOTTLE Type 0: Not a Combination Product06/05/2002
2NDC:0781-6102-5775 mL in 1 BOTTLE Type 0: Not a Combination Product18/12/2023
3NDC:0781-6102-5250 mL in 1 BOTTLE Type 0: Not a Combination Product15/05/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065066 06/05/2002
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6104
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID57 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MANNITOL(UNII: 3OWL53L36A)
ORANGE(UNII: 5EVU04N5QU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-6104-46100 mL in 1 BOTTLE Type 0: Not a Combination Product06/05/2002
2NDC:0781-6104-5775 mL in 1 BOTTLE Type 0: Not a Combination Product18/12/2023
3NDC:0781-6104-5250 mL in 1 BOTTLE Type 0: Not a Combination Product18/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065066 06/05/2002
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1619
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID28.5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
BANANA(UNII: 4AJZ4765R9)
CHERRY(UNII: BUC5I9595W)
FD&C RED NO. 40(UNII: WZB9127XOA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code GGN2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1619-665 in 1 CARTON 18/04/2002
14 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065065 04/18/2002 07/20/2016
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1643
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
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID57 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
BANANA(UNII: 4AJZ4765R9)
CHERRY(UNII: BUC5I9595W)
FD&C RED NO. 40(UNII: WZB9127XOA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 15 mm
Flavor Imprint Code GGN4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1643-665 in 1 CARTON 18/04/2002
14 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065065 04/18/2002 07/20/2016

LABELER - Sandoz Inc(005387188)

PRINCIPAL DISPLAY PANEL

250-125mg-label

NDC 0781-1874-31

Amoxicillin

And Clavulanate

Potassium

Tablets, USP

250 mg/125 mg*

Rx Only

30 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL

500-125mg-label

NDC 0781-1831-20

Amoxicillin

And Clavulanate

Potassium

Tablets, USP

500 mg/125 mg*

Rx Only

20 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL

875-125mg-label

NDC 0781-1852-20

Amoxicillin

And Clavulanate

Potassium

Tablets, USP

875 mg/125 mg*

Rx Only

20 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL

200mg-os-label

NDC 0781-6102-46

Amoxicillin and

Clavulanate

Potassium for Oral

Suspension, USP

200 mg/28.5 mg (per 5 mL)

Rx only

100 mL (when reconstituted)

When reconstituted,

each 5 mL contains:

AMOXICILLIN, 200 mg,

as the trihydrate

CLAVULANIC ACID, 28.5 mg,

as clavulanate potassium

SANDOZ

PRINCIPAL DISPLAY PANEL

400mg-os-label

NDC 0781-6104-46

Amoxicillin and

Clavulanate

Potassium for Oral

Suspension, USP

400 mg/57 mg (per 5 mL)

Rx only

100 mL (when reconstituted)

When reconstituted,

each 5 mL contains:

AMOXICILLIN, 400 mg,

as the trihydrate

CLAVULANIC ACID, 57 mg,

as clavulanate potassium

SANDOZ

PRINCIPAL DISPLAY PANEL

200-28.5mg-chewable-carton

NDC 0781-1619-66

Amoxicillin and Clavulanate

Potassium Tablets, USP

(Chewable)

200 mg/28.5 mg*

Rx only

20 Chewable Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL

400-57mg-chewable-carton

NDC 0781-1643-66

Amoxicillin and Clavulanate

Potassium Tablets, USP

(Chewable)

400 mg/57 mg*

Rx only

20 Chewable Tablets

SANDOZ