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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem tartrateZOLPIDEM TARTRATESandoz Incb1b0085f-d9fe-430a-9bd5-607f607bf7e12024-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC08411424-e8a8-4964-bd04-5b0b5aa5baaf2024-04-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack70d7cfc3-7e54-4cd8-8911-7cf115d5c8202024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack23bce69d-7918-42c2-8020-e22f292ff31f2024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack3aa7e88b-7929-45ac-9e81-03f4abf28e942024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack1e5b61b6-a5bd-4f09-9d34-905ce32f18992024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAurobindo Pharma Limitedea2067bd-1622-4d98-8012-2c09405aa88d2024-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATENorthStar Rx LLC51c9a29c-a285-40d0-bf3a-7e8c944ee39c2024-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC39d91478-ea0e-407e-b5cb-0eeb592e0aa42024-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackdf130798-1458-455b-a4e1-c33c4ecee43b2023-12-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack33094305-4bbd-4b52-9079-8853d5f836822023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEACI Healthcare USA, Inc021153ce-fe27-4ed1-8d88-b4157b0ed7342023-11-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATESun Pharmaceutical Industries, Inc.0c64bc71-2e7f-4b15-a8e1-acb8de04395f2023-10-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutionse68a1b3b-b3d1-495e-be46-466113e7dbd62023-09-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions67cc924a-26e0-431f-9160-32c9d92a46cd2023-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEProficient Rx LPacf9f431-3013-4cfd-ba4d-c4013f20bdab2022-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZOLPIDEM TARTRATE
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC8581cfad-525b-4b16-b116-a5138d9fda522022-10-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAsclemed USA, Inc.35f6c1ab-a61c-4625-b932-11a7483f1d842022-10-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zolpidem Tartrate
generic name: ZOLPIDEM TARTRATE
EdluarZOLPIDEM TARTRATEViatris Specialty LLCa32884d0-85b5-11de-8a39-0800200c9a662022-08-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEProficient Rx LPf76eb9d8-ca7d-4479-bd16-52a57f623b022022-08-01Boxed 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