FDA.reportPublic FDA data

NDC 68788-9127-02 - ZOLPIDEM TARTRATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68788-9127
Requested NDC
68788-9127-02
Package NDCs from labels
68788-9127-2, 68788-9127-3, 68788-9127-6, 68788-9127-9, 68788-9127-02
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2025-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZOLPIDEM TARTRATE - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2025-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9127-2ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET2812
68788-9127-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET3012
68788-9127-6ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET6012
68788-9127-9ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9127ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 4 package rows20240906_a9ac3d4e-f502-41e3-95c0-0d334584566d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9127-3EA - Each68788-9127ae8c5825-18e0-4e16-9aa9-277d20f1294612019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3

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 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
ndc (product): 13668-007
ndc (product): 13668-008
rxcui: 854876
rxcui: 854873
spl id: d9481da2-be07-4d0e-8316-9bea2dc953ce
spl set id: 1584bad1-7bf4-4805-bdd9-7eb0fac92721
unii: WY6W63843K
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Zolpidem TartrateZOLPIDEM TARTRATEBreckenridge Pharmaceutical, Inc.cbda91f7-4411-4016-80d6-0a349931956d2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack413b6f65-101e-e2cf-0802-711d080b851b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEREMEDYREPACK INC.2abdcf77-d3ed-42bc-acd9-545aab75d5672026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy507225e2-80ba-18c4-e054-00144ff88e882026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Zolpidem TartrateZOLPIDEM TARTRATETORRENT PHARMACEUTICALS LIMITED9025a6f7-5501-4aba-875e-222ef39848c02026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepack90201886-86a5-4c59-a4f1-98270d6207312026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepackbf99cd5c-9671-45a6-bda9-3dfc8252efdd2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy89cfb1d5-437c-4c13-8f9b-b6851ffba87b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.