FDA.reportPublic FDA data

NDC 0228-3482-50 - 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
0228-3482
Requested NDC
0228-3482-50
Package NDCs from labels
0228-3482-11, 0228-3482-50
Manufacturer
Bryant Ranch Prepack
Effective date
2021-04-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem Tartrate - Bryant Ranch PrepackBryant Ranch Prepack2021-04-27HUMAN PRESCRIPTION DRUG LABEL
Zolpidem Tartrate - Actavis Pharma, Inc.Actavis Pharma, Inc.2019-03-31HUMAN PRESCRIPTION DRUG LABEL
Zolpidem Tartrate - Lake Erie Medical DBA Quality Care Products LLCLake Erie Medical DBA Quality Care Products LLC2017-02-15HUMAN 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
0228-3482-11EA - Each0228-3482400786be-fedb-46ba-b092-65d39fda38e812012-07-24
0228-3482-50EA - Each0228-3482df645339-750e-4c4e-9969-ae61603b99a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8

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 2 of 152 · 3,031 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
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
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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