Zolpidem Tartrate

Product NDC
68788-7407
Requested package NDC
68788-7407-3
11-digit product format
687887407
Labeler code
68788
Product ID
68788-7407_267029ca-f29c-4455-8ef1-0dce36ac9397
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA021774
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-06-06
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-740768788-7407-3DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021774-001AMBIEN CRZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02
N021774-002AMBIEN CRZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021774-001AB
N021774-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02782e0a99824c…
2021-12-28 21:50 UTC2021-12N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021774-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021774-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021774-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021774-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021774-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021774-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021774-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021774-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021774-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021774-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021774-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021774-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021774-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021774-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021774-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021774-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021774-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021774-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021774-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021774-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021774-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021774-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021774-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021774-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021774-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021774-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021774-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021774-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021774-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021774-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021774-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021774-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021774-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021774-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021774-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021774-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021774-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021774-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021774-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021774-002AB1782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021774-00165145312019-12-01Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021774-0016514531*PED2020-06-01Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021774-00265145312019-12-01Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021774-0026514531*PED2020-06-01Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021774-0016514531*PED2020-06-01Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021774-0026514531*PED2020-06-01Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021774-0016514531*PED2020-06-01Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021774-0026514531*PED2020-06-01Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021774-00165145312019-12-01Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021774-0016514531*PED2020-06-01Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021774-00265145312019-12-01Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021774-0026514531*PED2020-06-01Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021774-00165145312019-12-01Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021774-0016514531*PED2020-06-01Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021774-00265145312019-12-01Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021774-0026514531*PED2020-06-01Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021774-00165145312019-12-01Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021774-0016514531*PED2020-06-01Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021774-00265145312019-12-01Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021774-0026514531*PED2020-06-01Pediatric extensionea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7407-2EA - Each68788-7407f3ba7e48-4150-4b86-a2d5-7491aa5cd52a12018-08-13
68788-7407-3EA - Each68788-74077a043f46-9c16-4f0d-9056-c2c8c43c72aa12018-08-13
68788-7407-6EA - Each68788-7407f6a51285-e4b4-4f46-8595-fa5c3ccc37f912018-08-13
68788-7407-9EA - Each68788-74074af0ca33-f552-41ba-b604-5584b36ce18112018-08-13

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
zolpidem tartrateZOLPIDEM TARTRATEGolden State Medical Supply, Inc.41124767-8ff7-da5d-e063-6394a90a52032025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021774
application number: NDA021774
Ambien CRZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.2d934da3-bd77-4470-e063-6294a90a64f52025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021774
application number: NDA021774
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC39d91478-ea0e-407e-b5cb-0eeb592e0aa42024-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021774
application number: NDA021774
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LPfacfc337-3447-4052-a9aa-8aa55282a3e32019-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021774
application number: NDA021774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7407-36878874070330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7407-3) 2018-06-060000-00-00NoNoCurrent