FDA.reportPublic FDA data

NDC 63672-3005-1 - 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
63672-3005
Requested NDC
63672-3005-1
Package NDCs from labels
63672-3005-1, 63672-3005-2
Manufacturer
Synthon Pharmaceuticals, Inc.
Effective date
2007-05-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem tartrate - Synthon Pharmaceuticals, Inc.Synthon Pharmaceuticals, Inc.2007-05-09HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63672-3005-1Zolpidem tartrate100 in 1 BOTTLETABLET, FILM COATED1001
63672-3005-2Zolpidem tartrate500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63672-3005ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]12 package rows20070614_AE0B595A-36D2-44F3-84F6-7FE9F995F4A1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63672-3005-1EA - Each63672-3005ec39a29b-aa01-4e4c-94b1-28f725215ffa12015-10-02
63672-3005-2EA - Each63672-3005c878750d-86c4-4aa7-8f73-7d665667966212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zolpidem tartrateACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
ZolpidemACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
hypromelloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
iron oxide redINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
lactoseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
polyethylene glycolINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
sodium starch glycolateINACTIVE INGREDIENTZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED FOR ORAL USE - CIV [SYNTHON PHARMACEUTICALS, INC.]1

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack413b6f65-101e-e2cf-0802-711d080b851b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEREMEDYREPACK INC.2abdcf77-d3ed-42bc-acd9-545aab75d5672026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy507225e2-80ba-18c4-e054-00144ff88e882026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy89cfb1d5-437c-4c13-8f9b-b6851ffba87b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.cf3dcbde-b92a-4802-98e4-14f00abdf99e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEGolden State Medical Supply, Inc.2b5cf535-ccdc-ecd7-e063-6394a90a726e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.0f8488f3-851d-4111-af23-60f420aad0d62026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEThe ACME Laboratories Ltd.5679ed64-8424-4e63-a3c9-91d80fff2ca62026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions2556c804-7a5e-4dbd-aeef-a3ba3a247c392026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsf67ef513-1b2c-42fe-bf33-4c7e9db191a32026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECalvin Scott & Co., Inc.7da75d2b-905c-4fdf-bc53-1358c64777552026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirect_Rx907c7b18-2638-512c-e053-2995a90ae6fd2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATENorthwind Health Company, LLC47212207-52a1-938b-e063-6294a90abca82025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENorthwind Health Company, LLC26e20f53-c042-eac0-e063-6394a90acfca2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions91511d2f-7066-49a0-90ea-2940d955c85e2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsef72eb73-d058-4ca3-9013-691aae8426fb2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECardinal Health 107, LLC83510333-f07d-4b81-a3ae-2801d114bd312025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc.a9ac3d4e-f502-41e3-95c0-0d334584566d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873

Reported adverse events (FAERS/openFDA)#

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