FDA.reportPublic FDA data

NDC 0054-0086-25 - 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
0054-0086
Requested NDC
0054-0086-25
Package NDCs from labels
0054-0086-29, 0054-0086-25
Manufacturer
Roxane Laboratories, Inc | Boehringer Ingelheim Roxane Inc | Assia Chemical Industries Ltd. - Teva Tech Site
Effective date
2013-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem TartrateRoxane Laboratories, Inc | Boehringer Ingelheim Roxane Inc | Assia Chemical Industries Ltd. - Teva Tech Site2013-05-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-0086-292024-02-22C16284748780-19d75b9d0-a603-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Zolpidem Tartrate Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets. Zolpidem Tartrate Tablets for oral administration C-IV Initial U.S. Approval: 1992
0054-0086-292020-01-31C16284748780-19d75b9d0-a603-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Zolpidem Tartrate Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets. Zolpidem Tartrate Tablets for oral administration C-IV Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0086-25EA - Each0054-0086ff8569d6-b83d-442d-9278-46126ca3c3ef12012-07-24
0054-0086-29EA - Each0054-008682b6e429-a3e2-445e-83cc-cf9063ee5bc312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]9

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 141 · 2,815 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Zolpidem TartrateZOLPIDEM TARTRATEBreckenridge Pharmaceutical, Inc.cbda91f7-4411-4016-80d6-0a349931956d2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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