NDC Code(s) : 10544-897-20
Packager : Blenheim Pharmacal, 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:10544-897(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, UNSPECIFIED(UNII: 2S7830E561)
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:10544-897-2020 in 1 BOTTLE Type 0: Not a Combination Product06/03/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091568 02/10/2015 06/07/2017

PRINCIPAL DISPLAY PANEL

Blenheim Pharmacal, Inc.
NDC 10544-897-20
Amoxicillin and
Clavulanate Potassium
Tablets, USP
875 mg/125 mg*
Rx only 20 Tablets
Label Graphic- 875mg/ 125mg