DailyMed - VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

NDC Code(s): 70771-1485-0, 70771-1485-4, 70771-1485-9, 70771-1486-0, view more
70771-1486-4, 70771-1486-9, 70771-1487-0, 70771-1487-4, 70771-1487-9, 70771-1488-0, 70771-1488-4, 70771-1488-9, 70771-1489-0, 70771-1489-4, 70771-1489-9
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2022

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg

NDC 70771-1485-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg

NDC 70771-1486-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg

NDC 70771-1487-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg

NDC 70771-1488-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg

NDC 70771-1489-0 in bottle of 1000 tablets

1000 tablets

Rx only

INGREDIENTS AND APPEARANCE

VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1485
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (PINK)	Score	no score
Shape	OVAL (OVAL)	Size	12mm
Flavor		Imprint Code	279
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1485-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
2	NDC:70771-1485-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
3	NDC:70771-1485-4	10 in 1 CARTON	02/12/2020
3		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	ANDA203000	02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1486
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	160 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)

Product Characteristics
Color	BROWN (brownish red)	Score	no score
Shape	OVAL (OVAL)	Size	17mm
Flavor		Imprint Code	280
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1486-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
2	NDC:70771-1486-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
3	NDC:70771-1486-4	10 in 1 CARTON	02/12/2020
3		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	ANDA203000	02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1487
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	160 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)

Product Characteristics
Color	BROWN (BROWN)	Score	no score
Shape	OVAL (oval)	Size	17mm
Flavor		Imprint Code	282
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1487-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
2	NDC:70771-1487-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
3	NDC:70771-1487-4	10 in 1 CARTON	02/12/2020
3		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	ANDA203000	02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1488
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	320 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (pink)	Score	no score
Shape	OVAL (oval)	Size	21mm
Flavor		Imprint Code	281
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1488-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
2	NDC:70771-1488-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
3	NDC:70771-1488-4	10 in 1 CARTON	02/12/2020
3		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	ANDA203000	02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1489
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	320 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BROWN)	Score	no score
Shape	OVAL (OVAL)	Size	21mm
Flavor		Imprint Code	283
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1489-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
2	NDC:70771-1489-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2020
3	NDC:70771-1489-4	10 in 1 CARTON	02/12/2020
3		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	ANDA203000	02/12/2020

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489) , MANUFACTURE(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489)

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Published Date (What is this?)	Version	Files
Nov 9, 2022	4 (current)	download
Sep 24, 2020	3	download
Feb 12, 2020	2	download

	RxCUI	RxNorm NAME	RxTTY
1	200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	PSN
2	200284	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet	SCD
3	200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	SY
4	200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN
5	200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD
6	200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY
7	349353	valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN
8	349353	hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD
9	349353	HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY
10	636042	valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN
11	636042	hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet	SCD
12	636042	HCTZ 12.5 MG / valsartan 320 MG Oral Tablet	SY
13	636045	valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN
14	636045	hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD
15	636045	HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY

Label: VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

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	NDC
1	70771-1485-0
2	70771-1485-4
3	70771-1485-9
4	70771-1486-0
5	70771-1486-4
6	70771-1486-9
7	70771-1487-0
8	70771-1487-4
9	70771-1487-9
10	70771-1488-0
11	70771-1488-4
12	70771-1488-9
13	70771-1489-0
14	70771-1489-4
15	70771-1489-9

Label: VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

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Drug Label Information

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Safety

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More Info on this Drug

VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Number of versions: 3

VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

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VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.