Tamoxifen Citrate (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg — (60 Tablets Bottle)

NDC 59651-299-60
Rx only
Tamoxifen Citrate
Tablets, USP
10 mg*
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
This is a unit-of-use container.AUROBINDO 60 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg -- (60 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg — (30 Tablets Bottle)

NDC 59651-300-30
Rx only
Tamoxifen Citrate
Tablets, USP
20 mg*
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
This is a unit-of-use container.

AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg -- (30 Tablets Bottle)
(click image for full-size original)
TAMOXIFEN CITRATE tamoxifen citrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-299
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
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code T10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-299-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213358 08/14/2020
TAMOXIFEN CITRATE tamoxifen citrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-300
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
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code T20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-300-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59651-300-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213358 08/14/2020
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
EUGIA Pharma Specialities Limited 872201704 ANALYSIS (59651-299), ANALYSIS (59651-300), MANUFACTURE (59651-299), MANUFACTURE (59651-300)

Revised: 08/2020 Aurobindo Pharma Limited

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