NDC Code(s) : 42571-160-30, 42571-160-01, 42571-160-32, 42571-160-11, 42571-161-42, 42571-161-01, 42571-161-32, 42571-161-11, 42571-162-42, 42571-162-01, 42571-162-43, 42571-162-44
Packager : Micro Labs 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 Item Code (Source) NDC:42571-160
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)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (biconvex) Size 17 mm
Flavor Imprint Code I05
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-160-3030 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
2NDC:42571-160-01100 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
3NDC:42571-160-1110 in 1 CARTON 03/01/2017
3NDC:42571-160-3210 in 1 BLISTER PACK Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205707 03/01/2017
AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-161
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)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (biconvex) Size 19 mm
Flavor Imprint Code I06
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-161-4220 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
2NDC:42571-161-01100 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
3NDC:42571-161-1110 in 1 CARTON 03/01/2017
3NDC:42571-161-3210 in 1 BLISTER PACK Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205707 03/01/2017
AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-162
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)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape CAPSULE (biconvex) Size 22 mm
Flavor Imprint Code I07
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-162-4220 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
2NDC:42571-162-01100 in 1 BOTTLE Type 0: Not a Combination Product03/01/2017
3NDC:42571-162-444 in 1 CARTON 03/01/2017
3NDC:42571-162-434 in 1 BLISTER PACK Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204755 03/01/2017

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 867064609 analysis(42571-160, 42571-161, 42571-162), label(42571-160, 42571-161, 42571-162), manufacture(42571-160, 42571-161, 42571-162), pack(42571-160, 42571-161, 42571-162)

PRINCIPAL DISPLAY PANEL

NDC 42571-160-30
Amoxicillin and Clavulanate
Potassium Tablets, USP
250 mg/125 mg*
Rx Only
30 Tablets
MICRO LABS LIMITED


amoxi-250125mg.jpg


NDC 42571-161-42
Amoxicillin and Clavulante
Potassium Tablets, USP
500 mg/125 mg*
Rx Only
20 Tablets
MICRO LABS LIMITED


amoxi-250125mg.jpg


NDC 42571-162-42
Amoxicillin and Clavulanate
Potassium Tablets, USP
875 mg/125 mg*
Rx Only
20 Tablets
MICRO LABS LIMITED

amoxi-250125mg.jpg