Abacavir (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300mg
(click image for full-size original)

ABACAVIR abacavir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-049(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:50268-049-12 20 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-049-11)
1 NDC:50268-049-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-049-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091560 04/10/2020
Labeler — AvPAK (832926666)

Revised: 05/2022 AvPAK

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