Label: COLCHICINE tablet
-
NDC Code(s):
70771-1396-1,
70771-1396-3,
70771-1396-5,
70771-1396-9, view more70771-1590-1, 70771-1590-3, 70771-1590-5, 70771-1590-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 26, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COLCHICINE
colchicine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1396 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COLCHICEINE (UNII: HJ30158L57) (COLCHICEINE - UNII:HJ30158L57) COLCHICEINE 0.6 mg Inactive Ingredients Ingredient Name Strength CARMINIC ACID (UNII: CID8Z8N95N) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PURPLE Score 2 pieces Shape CAPSULE Size 8mm Flavor Imprint Code 1351 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1396-3 1 in 1 CARTON 06/12/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70771-1396-9 1 in 1 CARTON 06/12/2019 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:70771-1396-1 1 in 1 CARTON 06/12/2019 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:70771-1396-5 1 in 1 CARTON 06/12/2019 4 500 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211519 06/12/2019 COLCHICINE
colchicine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1590 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COLCHICEINE (UNII: HJ30158L57) (COLCHICEINE - UNII:HJ30158L57) COLCHICEINE 0.3 mg Inactive Ingredients Ingredient Name Strength CARMINIC ACID (UNII: CID8Z8N95N) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PURPLE Score 2 pieces Shape ROUND (Round) Size 7mm Flavor Imprint Code 1571 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1590-3 1 in 1 CARTON 05/10/2021 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70771-1590-9 1 in 1 CARTON 05/10/2021 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:70771-1590-1 1 in 1 CARTON 05/10/2021 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:70771-1590-5 1 in 1 CARTON 05/10/2021 4 500 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211519 05/10/2021 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1396, 70771-1590) , MANUFACTURE(70771-1396, 70771-1590)