FDA.reportPublic FDA data

Application 220717

Type
ANDA
Sponsor
UMEDICA LABS PVT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATECAPSULE;ORAL7.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220717-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A220717-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12c2088c7a36db…
2026-09-14 22:38:342026-08A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-1284e616aacf4f…
2026-08-18 06:07:402026-07A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A220717-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A220717-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A220717-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220717-001AB1a50c72e98297…

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 3 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.d579c6ca-c820-49ff-92fb-2e6aaad3b0522025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.e5e2d31b-ce26-78b0-e053-2a95a90ac4912025-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
AmbienZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.747949c5-2c91-4909-8a07-71b6826f8e972025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Ambien CRZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.2d934da3-bd77-4470-e063-6294a90a64f52025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXc3f23bc3-595b-28e5-e053-2a95a90a9c2c2025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc.2b9f696a-b637-4dea-e063-6394a90aeb2e2025-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87ae17-a3c5-a3a5-e053-2a95a90aa4b02024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87b722-cdb7-0b17-e053-2a95a90a315b2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87df4e-2c97-e23e-e053-2a95a90ab3542024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCb2db3979-daa6-6e83-e053-2a95a90a3a2f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc8adec28-9dcd-4a7e-e053-2a95a90a991e2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc859c752-8a85-2017-e053-2a95a90a771f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCf939549f-14a6-d37c-e053-6294a90a034a2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLCdb735db9-1c82-4d32-bf91-97b05a75e8762024-12-17Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions3ba3c29f-3835-4f4f-a39f-56fb42686f5b2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem tartrateZOLPIDEM TARTRATEBryant Ranch Prepack82bca7a0-021f-4e35-8b3f-6390eeb863a62024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.95b0ba48-4e71-25f7-e053-2a95a90aea822024-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e13ad50-f846-813a-e063-6294a90a58782024-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATESandoz Inc0553e26c-f2aa-43aa-adf9-6eb951a501d32024-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE

Reported adverse events (FAERS/openFDA)#

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