FDA.reportPublic FDA data

hydrochlorothiazide

Product NDC
70518-1676
Requested package NDC
70518-1676-2
11-digit product format
705181676
Labeler code
70518
Product ID
70518-1676_e5cedec4-98fa-7aa2-e053-2995a90a5ae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090510
Marketing category
ANDA
Marketing start
2018-11-16
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-167670518-1676-2DDiscontinued by firm2026-07-31

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090510-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090510-001AB

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
2026-08-01 22:54:322026-06A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090510-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCe3afa83d-c79c-848a-e053-2a95a90ac9222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma Inc578f74ea-53d1-4c44-b872-66033292abe02025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging13ed002f-c5bb-401c-891a-70b70cbd8fb62025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEQuality Care Products LLCa2de8e26-ef5a-41c7-888b-990629b111452024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack6a11a458-dc69-40ba-a58a-649733e0e8ab2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.cb7712f3-9a0b-442d-859d-8be5e6e2529a2024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP98edae8a-99dc-4f26-a956-3ad58bf38a262022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1676-270518167602100 POUCH in 1 BOX (70518-1676-2) > 1 CAPSULE in 1 POUCH (70518-1676-3) 100 pouch2022-06-150000-00-00NoNoCurrent