Albendazole

ALBENDAZOLE- albendazole tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1103-7

Albendazole Tablets USP, 200 mg

28 Tablets

Rx only

Albendazole tablets
(click image for full-size original)
ALBENDAZOLE
albendazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBENDAZOLE (ALBENDAZOLE) ALBENDAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
SACCHARIN SODIUM
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND (ROUND) Size 12mm
Flavor Imprint Code 1021
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1103-7 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1103-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1103-5 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1103-8 1 BLISTER PACK in 1 BOTTLE contains a BLISTER PACK
4 2 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOTTLE (70771-1103-8)
5 NDC:70771-1103-6 2 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1103-3 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 2 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1103-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208979 12/17/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1103), MANUFACTURE (70771-1103)

Revised: 08/2020 Cadila Healthcare Limited

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