Label: ERLOTINIB tablet, film coated
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NDC Code(s):
70771-1521-2,
70771-1521-3,
70771-1521-7,
70771-1521-9, view more70771-1522-2, 70771-1522-3, 70771-1522-7, 70771-1522-9, 70771-1523-2, 70771-1523-3, 70771-1523-7, 70771-1523-9
- Packager: Cadila Healthcare Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated April 17, 2020
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INGREDIENTS AND APPEARANCE
ERLOTINIB
erlotinib tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1521 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E) ERLOTINIB 25 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (Off-white) Score no score Shape ROUND (Round) Size 6mm Flavor Imprint Code 913 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1521-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 2 NDC:70771-1521-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 3 NDC:70771-1521-7 3 in 1 CARTON 04/30/2020 3 NDC:70771-1521-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213065 04/30/2020 ERLOTINIB
erlotinib tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1522 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E) ERLOTINIB 100 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (Off-white) Score no score Shape ROUND (Round) Size 9mm Flavor Imprint Code 914 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1522-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 2 NDC:70771-1522-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 3 NDC:70771-1522-7 3 in 1 CARTON 04/30/2020 3 NDC:70771-1522-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213065 04/30/2020 ERLOTINIB
erlotinib tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1523 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E) ERLOTINIB 150 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (Off-white) Score no score Shape ROUND (Round) Size 11mm Flavor Imprint Code 915 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1523-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 2 NDC:70771-1523-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 3 NDC:70771-1523-7 3 in 1 CARTON 04/30/2020 3 NDC:70771-1523-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213065 04/30/2020 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1521, 70771-1522, 70771-1523) , MANUFACTURE(70771-1521, 70771-1522, 70771-1523)
