FDA.reportPublic FDA data

NDC 10370-116-50 - Zolpidem Tartrate Extended-Release

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
10370-116
Requested NDC
10370-116-50
Package NDCs from labels
10370-116-10, 10370-116-50
Manufacturer
Par Pharmaceutical, Inc.
Effective date
2022-05-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem Tartrate Extended-Release - Par Pharmaceutical, Inc.Par Pharmaceutical, Inc.2022-05-03HUMAN PRESCRIPTION DRUG LABEL
Zolpidem Tartrate Extended-Release - Golden State Medical SupplyGolden State Medical Supply2020-07-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-116-10EA - Each10370-11637ba7fd9-7b76-49df-87da-1313a8e8af0912012-07-24
10370-116-50EA - Each10370-11679dfd161-1822-4217-b5b5-814cf4c0b2ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
SUCROSEINACTIVE INGREDIENTC151H8M554ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17

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 142 · 2,833 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
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
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
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
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
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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