Label: FAMOTIDINE tablet, film coated
-
NDC Code(s):
70771-1702-0,
70771-1702-1,
70771-1702-2,
70771-1702-3, view more70771-1702-4, 70771-1702-5, 70771-1703-0, 70771-1703-1, 70771-1703-2, 70771-1703-3, 70771-1703-4, 70771-1703-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1702 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code Z21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1702-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 2 NDC:70771-1702-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 3 NDC:70771-1702-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 4 NDC:70771-1702-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 5 NDC:70771-1702-4 10 in 1 CARTON 06/06/2022 5 NDC:70771-1702-2 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 ANDA216441 06/06/2022 FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1703 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 40 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (off white) Score no score Shape ROUND Size 8mm Flavor Imprint Code Z41 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1703-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 2 NDC:70771-1703-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 3 NDC:70771-1703-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 4 NDC:70771-1703-4 10 in 1 CARTON 06/06/2022 4 NDC:70771-1703-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:70771-1703-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216441 06/06/2022 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1702, 70771-1703) , MANUFACTURE(70771-1702, 70771-1703)
