Zolpidem Tartrate

Product NDC
71610-770
Requested package NDC
71610-770-60
11-digit product format
716100770
Labeler code
71610
Product ID
71610-770_4602534f-29d4-4797-95d1-479735045513
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021774
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-10-14
Substance
ZOLPIDEM TARTRATE
Active strength
6.25 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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02c2088c7a36db…
2026-10-15 13:18:302026-09N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02c2088c7a36db…
2026-09-14 22:38:342026-08N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-0284e616aacf4f…
2026-09-14 22:38:342026-08N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-0284e616aacf4f…
2026-08-18 06:07:402026-07N021774-001AMBIEN CR12.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2005-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07N021774-002AMBIEN CR6.25MGTABLET, EXTENDED RELEASE / ORALABRLD2005-09-02caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021774-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021774-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08N021774-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N021774-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N021774-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021774-002AB1caaa826d4ba7…
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…

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE6.25 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
854894Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
39d91478-ea0e-407e-b5cb-0eeb592e0aa4Available 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
71610-770-15Zolpidem Tartrate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE151
71610-770-28Zolpidem Tartrate28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE281
71610-770-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
71610-770-53Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
71610-770-60Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-770-30EA - Each71610-77015b58ea5-1f71-4585-ba73-5b779c74e3b612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-770ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20240125_39d91478-ea0e-407e-b5cb-0eeb592e0aa4.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
ndc (package): 71610-770-60
ndc (product): 71610-770
ndc11 (package): 71610077060
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LPfacfc337-3447-4052-a9aa-8aa55282a3e32019-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021774
application number: NDA021774

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN39d91478-ea0e-407e-b5cb-0eeb592e0aa41
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD39d91478-ea0e-407e-b5cb-0eeb592e0aa41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-770-607161007706090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-60) 2024-01-19NoNoCurrent