COLCHICINE- colchicine tablet 
Zydus Lifesciences Limited

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COLCHICINE TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1396-3

Colchicine tablets, USP 0.6 mg

30 Tablets

Rx only

image

NDC 70771-1590-3

Colchicine tablets, USP 0.3 mg

30 Tablets

Rx only

label
COLCHICINE 
colchicine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1396
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COLCHICEINE (UNII: HJ30158L57) (COLCHICEINE - UNII:HJ30158L57) COLCHICEINE0.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore2 pieces
ShapeCAPSULESize8mm
FlavorImprint Code 1351
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1396-31 in 1 CARTON06/12/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70771-1396-91 in 1 CARTON06/12/2019
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:70771-1396-11 in 1 CARTON06/12/2019
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:70771-1396-51 in 1 CARTON06/12/2019
4500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21151906/12/2019
COLCHICINE 
colchicine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1590
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COLCHICEINE (UNII: HJ30158L57) (COLCHICEINE - UNII:HJ30158L57) COLCHICEINE0.3 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore2 pieces
ShapeROUND (Round) Size7mm
FlavorImprint Code 1571
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1590-31 in 1 CARTON05/10/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70771-1590-91 in 1 CARTON05/10/2021
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:70771-1590-11 in 1 CARTON05/10/2021
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:70771-1590-51 in 1 CARTON05/10/2021
4500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21151905/10/2021
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1396, 70771-1590) , MANUFACTURE(70771-1396, 70771-1590)

Revised: 11/2024
Document Id: 9bfd545b-8ea3-4758-b6dc-fff2e9af14ee
Set id: cd720ef0-1cb8-40bc-a657-10accb6542b6
Version: 5
Effective Time: 20241126
 
Zydus Lifesciences Limited