Tamoxifen Citrate

TAMOXIFEN CITRATE- tamoxifen citrate tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1184-1 in bottle of 100 tablets

Tamoxifen Citrate Tablets USP, 10 mg

Rx Only

100 tablets

tamoxifen tablets
(click image for full-size original)

NDC 70771-1185-1 in bottle of 100 tablets

Tamoxifen Citrate Tablets USP, 20 mg

Rx Only

100 tablets

tamoxifen tablets
(click image for full-size original)
TAMOXIFEN CITRATE
tamoxifen citrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1184
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMOXIFEN CITRATE (TAMOXIFEN) TAMOXIFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 826
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1184-6 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1184-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1184-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1184-8 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206694 01/03/2018
TAMOXIFEN CITRATE
tamoxifen citrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMOXIFEN CITRATE (TAMOXIFEN) TAMOXIFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 827
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1185-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1185-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1185-9 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1185-1 100 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1185-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206694 01/03/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1184), ANALYSIS (70771-1185), MANUFACTURE (70771-1184), MANUFACTURE (70771-1185)

Revised: 07/2020 Cadila Healthcare Limited

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