FDA.reportPublic FDA data

Application 215721

Type
NDA
Sponsor
ALMATICA

Application Products#

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

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
N215721-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE7.5MGCAPSULE / ORALABRLD, RS2023-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N215721-001AB

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 13:18:302026-09N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALABRLD, RS2023-05-09c2088c7a36db…
2026-09-14 22:38:342026-08N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALABRLD, RS2023-05-0984e616aacf4f…
2026-08-18 06:07:402026-07N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALABRLD, RS2023-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALRLD, RS2023-05-093f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215721-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALABRLD, RS2023-05-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N215721-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N215721-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N215721-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215721-001AB1a50c72e98297…

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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Zolpidem tartrateZOLPIDEM TARTRATEBryant Ranch Prepackce301d8b-0a8c-4404-8697-57222ae17a442024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem tartrate
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack8cef5718-c562-43c3-8abe-a2fc5235ad2a2024-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackfff2e7fc-2f7e-43c9-bfb3-d929ecc9eb722024-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAmerican Health Packagingeb850154-4b4b-4d9a-8476-aea1a93fe8d72024-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEChartwell RX, LLC0dd113e1-f789-48d2-8cb2-d39b712736582024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack3bbc3c35-2811-4a67-9dcc-5eed38ef8b522024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepackf9c108d1-5e2f-41c7-a845-2aed48c309052024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack604e77ef-2cda-4efc-abfb-9af549d40fd42024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack74c4e793-3444-4d3d-8211-26374349ab1e2024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC1fa86b79-8809-35f4-e063-6394a90a43772024-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.ac8c412a-0f94-7c3a-e053-2995a90afdc72024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc4be6ce23-e7b1-510e-e054-00144ff8d46c2024-07-16Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirectRX25f1176d-5195-1a99-e054-00144ff8d46c2024-06-26Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.98e5208b-5109-58c6-e053-2995a90a994a2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.92c6cc45-c28b-729b-e053-2a95a90a7ccb2024-06-19Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.78481108-4a1c-fce9-e053-2a91aa0a09ad2024-06-12Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1a8a8072-39bf-44c5-e063-6294a90a77c32024-06-10Boxed 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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77881ORIG 2024-03-20
74221ORIG 2023-05-11
74212ORIG 2023-05-10
74211ORIG 2023-05-10