TELMISARTAN AND HYDROCHLOROTHIAZIDE - telmisartan and hydrochlorothiazide tablet 
Zydus Lifesciences Limited

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TELMISARTAN AND HYDROCHLORTHIAZIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1123-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet

NDC 70771-1124-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet

NDC 70771-1125-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
TELMISARTAN AND HYDROCHLOROTHIAZIDE 
telmisartan and hydrochlorothiazide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN40 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Scoreno score
ShapeOVAL (Oblong Shaped) Size15mm
FlavorImprint Code 513
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1123-330 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
2NDC:70771-1123-990 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
3NDC:70771-1123-83 in 1 CARTON10/12/2017
3NDC:70771-1123-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20422110/12/2017
TELMISARTAN AND HYDROCHLOROTHIAZIDE 
telmisartan and hydrochlorothiazide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1124
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Scoreno score
ShapeOVAL (Oblong Shaped) Size17mm
FlavorImprint Code 514
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1124-330 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
2NDC:70771-1124-990 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
3NDC:70771-1124-83 in 1 CARTON10/12/2017
3NDC:70771-1124-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20422110/12/2017
TELMISARTAN AND HYDROCHLOROTHIAZIDE 
telmisartan and hydrochlorothiazide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1125
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorBROWN (Mottled Light brown to Mottled Brown) , YELLOW (YELLOW) Scoreno score
ShapeOVAL (Oblong Shaped) Size17mm
FlavorImprint Code 515
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1125-330 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
2NDC:70771-1125-990 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
3NDC:70771-1125-83 in 1 CARTON10/12/2017
3NDC:70771-1125-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20422110/12/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1123, 70771-1124, 70771-1125) , MANUFACTURE(70771-1123, 70771-1124, 70771-1125)

Revised: 10/2022
Document Id: 83bc89db-4caf-4b60-899e-fd45a1474650
Set id: cbcd600a-4499-4d54-9b50-171a51e8966f
Version: 5
Effective Time: 20221017
 
Zydus Lifesciences Limited