Hydrochlorothiazide

Product NDC
68071-4176
Requested package NDC
68071-4176-6
11-digit product format
680714176
Labeler code
68071
Product ID
68071-4176_bb64231a-3b27-3c15-e053-2a95a90ad079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA020504
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-12-27
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
2022-12-31
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 packagepackage68071-417668071-4176-6DDiscontinued 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
N020504-001MICROZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020504-001AB

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 22:54:322026-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020504-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.5bacc909-6b02-4815-85ef-55fd25b1b1f72025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEActavis Pharma, Inc.a3eb7294-f913-434b-896c-da028bfebc732024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc1052d38-fd75-40c2-a685-0e889009be0b2023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC0f7a608d-748b-49a9-a4b3-b3fdcab53ce02017-12-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4176-66807141760660 CAPSULE, GELATIN COATED in 1 BOTTLE (68071-4176-6) 2017-12-060000-00-00NoNoCurrent