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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENorthwind Health Company, LLC26e20f53-c042-eac0-e063-6394a90acfca2025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELupin Pharmaceuticals, Inc.ac647afe-2fe5-4056-806f-abdd54789b452025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions91511d2f-7066-49a0-90ea-2940d955c85e2025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsef72eb73-d058-4ca3-9013-691aae8426fb2025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
zolpidem tartrateZOLPIDEM TARTRATEGolden State Medical Supply, Inc.41124767-8ff7-da5d-e063-6394a90a52032025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zolpidem tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepack8425be72-2bbe-4090-b00e-610f1a1646b12025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc.a9ac3d4e-f502-41e3-95c0-0d334584566d2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.76ff87e4-3aa2-439d-8436-d9e6affb33c82025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc..72e19b8e-d13a-4824-aee4-11778eba552c2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.625fad5b-8817-4773-a2fc-20b662140e6e2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack028bf425-7a72-464d-a242-aa5deee1ac232025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEST. MARY'S MEDICAL PARK PHARMACY3bc8a122-aa21-212c-e063-6394a90a3bda2025-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAsclemed USA, Inc.9922ce14-b418-4235-9c59-d674a8e702102025-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC3882d72d-686b-406b-e063-6294a90a0b892025-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLCa1faca42-6e46-4586-97ac-050b724e7d2a2025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LP92c58053-7ed8-4a3d-a2f7-8e30c4e5a3672025-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC349053e4-9885-ec0b-e063-6294a90ad79a2025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e15d6e3-8d06-0936-e063-6394a90ab8db2025-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC3310d63e-d79a-175d-e063-6394a90a42702025-04-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
AmbienZOLPIDEM TARTRATESanofi-Aventis U.S. LLCc36cadf4-65a4-4466-b409-c82020b424522025-04-15Boxed warning, Warnings, Adverse reactionsName fallback
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