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

NDC 70771-1124-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg

Rx only

90 tablets

NDC 70771-1125-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg

Rx only

90 tablets

TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	40 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	OVAL (Oblong Shaped)	Size	15mm
Flavor		Imprint Code	513
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1123-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2017	03/25/2025
2	NDC:70771-1123-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2017	03/25/2025
3	NDC:70771-1123-8	3 in 1 CARTON	10/12/2017	03/25/2025
3	NDC:70771-1123-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204221	10/12/2017	05/14/2025

TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	OVAL (Oblong Shaped)	Size	17mm
Flavor		Imprint Code	514
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1124-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2017	03/25/2025
2	NDC:70771-1124-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2017	03/25/2025
3	NDC:70771-1124-8	3 in 1 CARTON	10/12/2017	03/25/2025
3	NDC:70771-1124-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204221	10/12/2017	05/14/2025

TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	BROWN (Mottled Light brown to Mottled Brown) , YELLOW (YELLOW)	Score	no score
Shape	OVAL (Oblong Shaped)	Size	17mm
Flavor		Imprint Code	515
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1125-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2017	03/25/2025
2	NDC:70771-1125-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2017	03/25/2025
3	NDC:70771-1125-8	3 in 1 CARTON	10/12/2017	03/25/2025
3	NDC:70771-1125-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204221	10/12/2017	05/14/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1123, 70771-1124, 70771-1125) , MANUFACTURE(70771-1123, 70771-1124, 70771-1125)

Revised: 12/2024

Document Id: 5f887b90-4855-457e-b8da-336dcc16c9bb

Set id: cbcd600a-4499-4d54-9b50-171a51e8966f

Version: 6

Effective Time: 20241204

Zydus Lifesciences Limited