FDA.reportPublic FDA data

NDC 16590-010-60 - AMBIEN

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
16590-010
Requested NDC
16590-010-60
Package NDCs from labels
16590-010-20, 16590-010-28, 16590-010-30, 16590-010-56, 16590-010-60
Manufacturer
STAT Rx USA LLC | PSS World Medical Inc.
Effective date
2012-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMBIEN - STAT Rx USA LLC | PSS World Medical Inc.STAT Rx USA LLC | PSS World Medical Inc.2012-09-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
16590-010-20These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992
16590-010-28These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992
16590-010-30These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992
16590-010-56These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16590-010-20AMBIEN20 in 1 BOTTLETABLET, FILM COATED203
16590-010-28AMBIEN28 in 1 BOTTLETABLET, FILM COATED283
16590-010-30AMBIEN30 in 1 BOTTLETABLET, FILM COATED303
16590-010-56AMBIEN56 in 1 BOTTLETABLET, FILM COATED563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16590-010AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]34 package rows20120920_02b5e3bb-c976-40a3-9077-64ffe637429f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16590-010-20EA - Each16590-0106dc51120-ba88-4d9d-9b8c-43f7d1fc96a112012-07-24
16590-010-30EA - Each16590-01004839d6b-0494-4ef6-83b8-893546ac53a812012-07-24
16590-010-60EA - Each16590-0104050f881-e386-4227-ae01-0042c01c72d712013-02-11
16590-010-90EA - Each16590-0108ec25c48-caa5-49fd-9218-c6c2f871ae4c12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
ZOLPIDEMACTIVE MOIETY7K383OQI23AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]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 110 · 2,184 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
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
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
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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