NDC Code(s) : 55111-496-60, 55111-496-05, 55111-497-04, 55111-497-05
Packager : Dr. Reddy's Laboratories Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

capecitabinecapecitabine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-496
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capecitabine(UNII: 6804DJ8Z9U)
(Capecitabine - UNII:6804DJ8Z9U) 		Capecitabine150 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose(UNII: 3SY5LH9PMK)
croscarmellose sodium(UNII: M28OL1HH48)
Hypromellose 2910 (6 Mpa.S)(UNII: 0WZ8WG20P6)
microcrystalline cellulose(UNII: OP1R32D61U)
magnesium stearate(UNII: 70097M6I30)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
ferric oxide yellow(UNII: EX438O2MRT)
ferric oxide red(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape RECTANGLE Size 4 mm
Flavor Imprint Code 150;RDY
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-496-6060 in 1 BOTTLE Type 0: Not a Combination Product12/10/2020
2NDC:55111-496-05500 in 1 BOTTLE Type 0: Not a Combination Product12/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204345 12/10/2020
capecitabinecapecitabine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-497
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capecitabine(UNII: 6804DJ8Z9U)
(Capecitabine - UNII:6804DJ8Z9U) 		Capecitabine500 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose(UNII: 3SY5LH9PMK)
croscarmellose sodium(UNII: M28OL1HH48)
Hypromellose 2910 (6 Mpa.S)(UNII: 0WZ8WG20P6)
microcrystalline cellulose(UNII: OP1R32D61U)
magnesium stearate(UNII: 70097M6I30)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
ferric oxide yellow(UNII: EX438O2MRT)
ferric oxide red(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape RECTANGLE Size 6 mm
Flavor Imprint Code 500;RDY
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-497-04120 in 1 BOTTLE Type 0: Not a Combination Product12/10/2020
2NDC:55111-497-05500 in 1 BOTTLE Type 0: Not a Combination Product12/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204345 12/10/2020

LABELER - Dr. Reddy's Laboratories Limited(650562841)

Establishment
Name Address ID/FEI Business Operations
Dr. Reddy's Laboratories Limited - FTO7 650446243 analysis(55111-496, 55111-497), manufacture(55111-496, 55111-497)

PRINCIPAL DISPLAY PANEL

Capecitabine Tablets USP, 150 mg - Container Label

PRINCIPAL DISPLAY PANEL

Capecitabine Tablets USP, 500 mg - Container Label