FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
67296-1591
Requested package NDC
67296-1591-6
11-digit product format
672961591
Labeler code
67296
Product ID
67296-1591_d61c28e6-9c53-12db-e053-2a95a90a4e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076410
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
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 packagepackage67296-159167296-1591-6IInactivated 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076410-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23
A076410-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23

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 22:54:322026-06A076410-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23a50c72e98297…
2026-08-01 22:54:322026-06A076410-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LPe534b3ac-1110-465f-8692-6ea585996fb62019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076410
application number: ANDA076410
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LPe8572fd4-70c7-4c94-a0d7-9b4be6fa8f772019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076410
application number: ANDA076410

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1591-62024-01-30C16284748780-11030e365-66b3-111a-e063-dadaa90a10e2zolpidem

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1591-6Zolpidem Tartrate6 in 1 BOTTLETABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1591ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220122_6a123164-e688-5ce3-e053-2a91aa0a76bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN6a123164-e688-5ce3-e053-2a91aa0a76bc3
854876zolpidem tartrate 5 MG Oral TabletSCD6a123164-e688-5ce3-e053-2a91aa0a76bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1591-6672961591066 TABLET, FILM COATED in 1 BOTTLE (67296-1591-6) 2018-01-010000-00-00NoNoCurrent