Abacavir (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container label for Abacavir Tablets, 300 mg, 60s count

Abacavircontaier60s
(click image for full-size original)

Container carton for Abacavir Tablets, 300 mg, 60s count

Abacavircarton
(click image for full-size original)
ABACAVIR abacavir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-557
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
POLYSORBATE 80
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE Size 18mm
Flavor Imprint Code H;139
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-557-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091560 09/18/2013
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 ANALYSIS (31722-557), MANUFACTURE (31722-557)

Revised: 11/2019 Camber Pharmaceuticals, Inc.

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