Maraviroc (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maraviroc Tablet 150 mg Label

maraviroctablet150mglabel
(click image for full-size original)

Maraviroc Tablet 300 mg Label

maraviroctablet300mglabel
(click image for full-size original)
MARAVIROC maraviroc tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-579
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MARAVIROC (MARAVIROC) MARAVIROC 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF WHITE) Score no score
Shape OVAL (biconvex) Size 15mm
Flavor Imprint Code J;62
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-579-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203347 02/06/2022
MARAVIROC maraviroc tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-580
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MARAVIROC (MARAVIROC) MARAVIROC 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF WHITE) Score no score
Shape OVAL (biconvex) Size 19mm
Flavor Imprint Code J;63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-580-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203347 02/06/2022
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 manufacture (31722-579), manufacture (31722-580)

Revised: 01/2022 Camber Pharmaceuticals, Inc.

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