FDA.reportPublic FDA data

HYDROCHLOROTHIAZIDE

Product NDC
61919-580
Requested package NDC
61919-580-90
11-digit product format
619190580
Labeler code
61919
Product ID
61919-580_f214c893-efe7-b30b-e053-2a95a90a4fb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090510
Marketing category
ANDA
Marketing start
2019-08-21
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
2024-12-31
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 packagepackage61919-58061919-580-90IInactivated by FDA2026-07-31

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-580-902025-01-30C16284748780-12cef2736-8f95-d83d-e063-dadaa90ab31fHYDROCHLOROTHIAZIDE
61919-580-302020-01-31C16284748780-19d75b9d0-35ad-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-580-712020-01-31C16284748780-19d75b9d0-35ad-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-580-30HYDROCHLOROTHIAZIDE30 in 1 BOTTLECAPSULE304
61919-580-71HYDROCHLOROTHIAZIDE100 in 1 BOTTLECAPSULE1004
61919-580-90HYDROCHLOROTHIAZIDE90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-580-30EA - Each61919-5803eb530af-f45c-40c2-9e31-59619685aa8712015-03-03
61919-580-71EA - Each61919-5804b40713b-fce9-4b1c-a316-9af5b6b95a4712015-11-12
61919-580-90EA - Each61919-580dca9282c-17ce-48b7-8329-2f3765947f0e12019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-580HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]4Legacy NDC, 2 package rows20161020_b0f2e5c7-2135-4154-bde7-9080e95d3e91.zip
61919-580HYDROCHLOROTHIAZIDE CAPSULE [DIRECT_RX]4Legacy NDC, 1 package rows20230113_90a0a64c-1c98-f27b-e053-2a95a90a8ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNb0f2e5c7-2135-4154-bde7-9080e95d3e914
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDb0f2e5c7-2135-4154-bde7-9080e95d3e914
199903HCTZ 12.5 MG Oral CapsuleSY90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903HCTZ 12.5 MG Oral CapsuleSYb0f2e5c7-2135-4154-bde7-9080e95d3e914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-580-906191905809090 CAPSULE in 1 BOTTLE (61919-580-90) 90 capsule2019-08-210000-00-00NoNoCurrent