Zolpidem Tartrate

Product NDC
63187-862
11-digit product format
631870862
Labeler code
63187
Product ID
63187-862_16ffd293-15a1-4014-9b06-6772decd7651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021774
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-12-06
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Zolpidem Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WY6W63843KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854880Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
facfc337-3447-4052-a9aa-8aa55282a3e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-862-15Zolpidem Tartrate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE153
63187-862-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
63187-862-60Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
63187-862-90Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-862-30EA - Each63187-862aa97079a-da52-44e5-b52d-635fb2e45c7a12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-862ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191113_facfc337-3447-4052-a9aa-8aa55282a3e3.zip

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
ndc (product): 63187-862

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNfacfc337-3447-4052-a9aa-8aa55282a3e33
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDfacfc337-3447-4052-a9aa-8aa55282a3e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-862-156318708621515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-15) 2017-06-010000-00-00NoNoCurrent
63187-862-306318708623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-30) 2017-06-010000-00-00NoNoCurrent
63187-862-606318708626060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-60) 2017-06-010000-00-00NoNoCurrent
63187-862-906318708629090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-90) 2017-06-010000-00-00NoNoCurrent