FDA.reportPublic FDA data

NDC 68180-780-11 - 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
68180-780
Requested NDC
68180-780-11
Package NDCs from labels
68180-780-06, 68180-780-02, 68180-780-03, 68180-780-11, 68180-780-04, 68180-780-01
Manufacturer
St. Mary's Medical Park Pharmacy
Effective date
2026-06-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZOLPIDEM TARTRATE - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2026-06-04HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-02-19HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-12-26HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM - Preferred Pharmaceuticals, Inc.. | Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.. | Preferred Pharmaceuticals, Inc.2025-10-08HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - A-S Medication SolutionsA-S Medication Solutions2025-05-28HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-04-11HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - DIRECT RXDIRECT RX2025-01-20HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-28HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2024-04-12HUMAN PRESCRIPTION DRUG LABEL
ZOLPIDEM TARTRATE - Proficient Rx LPProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-780-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10022
68180-780-02ZOLPIDEM TARTRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE50022
68180-780-03ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100022
68180-780-04ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10022
68180-780-06ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE3022
68180-780-11ZOLPIDEM TARTRATE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-780ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 6 package rows20250125_ac647afe-2fe5-4056-806f-abdd54789b45.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-780-01EA - Each68180-7804030af0d-cdfc-4c37-886d-bbaaa96de43712014-05-02
68180-780-04EA - Each68180-780387907ae-61c1-499b-a3ad-b3313d95204412024-06-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]5
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]5

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 6 · 117 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
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBreckenridge Pharmaceutical, Inc.cbda91f7-4411-4016-80d6-0a349931956d2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854894
rxcui: 854880
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack413b6f65-101e-e2cf-0802-711d080b851b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEREMEDYREPACK INC.2abdcf77-d3ed-42bc-acd9-545aab75d5672026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy507225e2-80ba-18c4-e054-00144ff88e882026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATETORRENT PHARMACEUTICALS LIMITED9025a6f7-5501-4aba-875e-222ef39848c02026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
310b7eb7-f2e5-4072-a617-a9da0baf105ab96e0270-d3e0-4d24-b575-ec0c130fad2b2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: b96e0270-d3e0-4d24-b575-ec0c130fad2b
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepack90201886-86a5-4c59-a4f1-98270d6207312026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854880
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepackbf99cd5c-9671-45a6-bda9-3dfc8252efdd2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078970
rxcui: 854894
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy89cfb1d5-437c-4c13-8f9b-b6851ffba87b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.cf3dcbde-b92a-4802-98e4-14f00abdf99e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy21767f56-ce92-2b8c-e063-6394a90a8b762026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078970
ndc (package): 60760-819-30
ndc (product): 60760-819
rxcui: 854880
spl id: 54e3c118-e620-ecca-e063-6294a90a6dd6
spl set id: 21767f56-ce92-2b8c-e063-6394a90a8b76
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEUmedica Laboratories USA Inc.b49f6c18-e155-4728-a79a-9354e8c3c8f42026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEGolden State Medical Supply, Inc.2b5cf535-ccdc-ecd7-e063-6394a90a726e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.0f8488f3-851d-4111-af23-60f420aad0d62026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem tartrate sublingualZOLPIDEM TARTRATE SUBLINGUALPar Health USA, LLC44b34e58-114b-4774-9fab-4b188dfe02282026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEThe ACME Laboratories Ltd.5679ed64-8424-4e63-a3c9-91d80fff2ca62026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.bca751bb-5161-5a95-e053-2a95a90aa2dd2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078970
ndc (package): 68071-2354-9
ndc (product): 68071-2354
rxcui: 854880
spl id: 4b3272fa-6308-bed3-e063-6394a90ac433
spl set id: bca751bb-5161-5a95-e053-2a95a90aa2dd
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions2556c804-7a5e-4dbd-aeef-a3ba3a247c392026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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