FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
65862-547
11-digit product format
658620547
Labeler code
65862
Product ID
65862-547_81a03db7-4be2-478d-b625-e59c8bd2235f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202519
Marketing category
ANDA
Marketing start
2013-03-21
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
12.5; 80 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
VALSARTAN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 80M03YXJ7I
Rxcui200284, 200285, 349353, 636042, 636045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-547-10Valsartan and Hydrochlorothiazide10 in 1 CARTONTABLET, FILM COATED1011
65862-547-10Valsartan and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET, FILM COATED1011
65862-547-90Valsartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9011
65862-547-99Valsartan and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-547-90EA - Each65862-54742b5c6a9-a071-493e-b666-8ca5512623dc12013-04-01
65862-547-99EA - Each65862-54703cb13bc-7fec-44c9-a8f0-0f03f039777512013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-547VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 4 package rows20240618_c5bc7c55-b50c-4e61-ad1f-5ebb607c262f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSN5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCD5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCD5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSY5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSY5ed6f8bd-baa0-45b9-96f8-980d5a09a68315
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSNc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCDc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCDc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSYc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSYc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYc5bc7c55-b50c-4e61-ad1f-5ebb607c262f11
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSNe1f94546-c71c-4175-9384-20238181e05f3
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCDe1f94546-c71c-4175-9384-20238181e05f3
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSYe1f94546-c71c-4175-9384-20238181e05f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-547-106586205471010 BLISTER PACK in 1 CARTON (65862-547-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-03-210000-00-00NoNoCurrent
65862-547-906586205479090 TABLET, FILM COATED in 1 BOTTLE (65862-547-90) 2013-03-210000-00-00NoNoCurrent
65862-547-99658620547991000 TABLET, FILM COATED in 1 BOTTLE (65862-547-99) 2013-03-210000-00-00NoNoCurrent