FDA.reportPublic FDA data

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product NDC
50228-147
Requested package NDC
50228-147-10
11-digit product format
502280147
Labeler code
50228
Product ID
50228-147_1d11c062-0075-4a21-bf41-61545d591adc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, INC.
Application
ANDA204687
Marketing category
ANDA
Marketing start
2026-07-27
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
12.5 mg/1; 80 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]; Increased Diuresis [PE]; Thiazide Diuretic [EPC]; Thiazides [CS]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204687-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALAB2026-04-23
A204687-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALAB2026-04-23
A204687-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALAB2026-04-23
A204687-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALAB2026-04-23
A204687-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALAB2026-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A204687-001AB
A204687-002AB
A204687-003AB
A204687-004AB
A204687-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2026-04-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2026-04-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2026-04-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2026-04-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2026-04-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204687-005AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
VALSARTAN AND HYDROCHLOROTHIAZIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN12.5 mg/1
HYDROCHLOROTHIAZIDE80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
80M03YXJ7IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200284Internal RxNorm lookup
200285Internal RxNorm lookup
349353Internal RxNorm lookup
636042Internal RxNorm lookup
636045Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
17362ff8-07bb-42c6-a100-8adb93be0348Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, INC.17362ff8-07bb-42c6-a100-8adb93be03482026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204687
application number: ANDA204687
ndc (package): 50228-147-10
ndc (product): 50228-147
ndc11 (package): 50228014710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
50228-147-10502280147101000 TABLET, FILM COATED in 1 BOTTLE (50228-147-10)2026-07-270Current