NDC Code(s) : 65862-501-30, 65862-501-05, 65862-502-20, 65862-502-05, 65862-503-20, 65862-503-01
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-501
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code A;63
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-501-3030 in 1 BOTTLE Type 0: Not a Combination Product20/01/2012
2NDC:65862-501-05500 in 1 BOTTLE Type 0: Not a Combination Product20/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091569 01/20/2012
Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-502
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL Size 20 mm
Flavor Imprint Code X;33
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-502-2020 in 1 BOTTLE Type 0: Not a Combination Product20/01/2012
2NDC:65862-502-05500 in 1 BOTTLE Type 0: Not a Combination Product20/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091569 01/20/2012
Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-503
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape CAPSULE Size 22 mm
Flavor Imprint Code X;3;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-503-2020 in 1 BOTTLE Type 0: Not a Combination Product20/01/2012
2NDC:65862-503-01100 in 1 BOTTLE Type 0: Not a Combination Product20/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091568 01/20/2012

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917683 ANALYSIS(65862-501, 65862-502, 65862-503), MANUFACTURE(65862-501, 65862-502, 65862-503)

PRINCIPAL DISPLAY PANEL

NDC 65862-501-30
Rx only 

Amoxicillin and
Clavulanate Potassium
Tablets, USP

250 mg/125 mg*

AUROBINDO               30 Tablets



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (30 Tablets Bottle)

PRINCIPAL DISPLAY PANEL

NDC 65862-502-20
Rx only
Amoxicillin and
Clavulanate Potassium
Tablets, USP
500 mg/125 mg*
AUROBINDO               20 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/125 mg (20 Tablets Bottle)

PRINCIPAL DISPLAY PANEL

NDC 65862-503-20
Rx only
Amoxicillin and
Clavulanate Potassium
Tablets, USP 
875 mg/125 mg*
AUROBINDO               20 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 875 mg/125 mg (20 Tablets Bottle)