TELMISARTAN- telmisartan tablet 
Cadila Healthcare Limited

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TELMISARTAN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-804-05 in bottle of 500 tablets

Telmisartan Tablets USP, 20 mg

Rx only

500 tablets

Telmisartan tablets, 20 mg

NDC 65841-805-05 in bottle of 500 tablets

Telmisartan Tablets USP, 40 mg

Rx only

500 tablets

Telmisartan Tablets, 40 mg

NDC 65841-806-05 in bottle of 500 tablets

Telmisartan Tablets USP, 80 mg

Rx only

500 tablets

Telmisartan Tablets, 80 mg
TELMISARTAN 
telmisartan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-804
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN20 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 471
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-804-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
2NDC:65841-804-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
3NDC:65841-804-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
4NDC:65841-804-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
5NDC:65841-804-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
6NDC:65841-804-7830 in 1 CARTON08/27/2014
6NDC:65841-804-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20332508/27/2014
TELMISARTAN 
telmisartan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-805
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN40 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POVIDONE (UNII: FZ989GH94E)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SORBITOL (UNII: 506T60A25R)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorBROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN) Scoreno score
ShapeOVAL (OBLONG) Size12mm
FlavorImprint Code 472
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-805-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
2NDC:65841-805-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
3NDC:65841-805-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
4NDC:65841-805-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
5NDC:65841-805-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
6NDC:65841-805-7830 in 1 CARTON08/27/2014
6NDC:65841-805-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20332508/27/2014
TELMISARTAN 
telmisartan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-806
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN80 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POVIDONE (UNII: FZ989GH94E)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SORBITOL (UNII: 506T60A25R)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorBROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN) Scoreno score
ShapeOVAL (OBLONG) Size18mm
FlavorImprint Code 473
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-806-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
2NDC:65841-806-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
3NDC:65841-806-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
4NDC:65841-806-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
5NDC:65841-806-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
6NDC:65841-806-7830 in 1 CARTON08/27/2014
6NDC:65841-806-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20332508/27/2014
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-804, 65841-805, 65841-806) , MANUFACTURE(65841-804, 65841-805, 65841-806)

Revised: 9/2020
Document Id: 2bd4ed33-85d4-4756-b60c-6f2861073acb
Set id: 2e3cc412-fa44-4304-aabc-d6e412f81fbf
Version: 6
Effective Time: 20200914
 
Cadila Healthcare Limited