ZOLPIDEM TARTRATE

Product NDC
68788-8654
Requested package NDC
68788-8654-9
11-digit product format
687888654
Labeler code
68788
Product ID
68788-8654_542b2687-71b1-4b46-bf3c-c3f28bfaa724
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078970
Marketing category
ANDA
Marketing start
2024-05-09
Substance
ZOLPIDEM TARTRATE
Active strength
6.25 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [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 43.

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
A078970-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11
A078970-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078970-001AB
A078970-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-1174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078970-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078970-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A078970-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078970-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078970-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078970-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078970-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078970-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078970-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078970-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078970-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078970-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078970-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078970-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078970-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078970-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078970-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078970-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078970-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078970-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078970-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078970-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078970-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078970-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078970-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078970-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078970-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078970-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078970-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078970-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078970-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078970-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078970-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078970-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078970-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078970-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078970-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078970-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078970-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078970-002AB174a2ff9319b5…

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
76ff87e4-3aa2-439d-8436-d9e6affb33c8Available 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
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
68788-8654-3ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
68788-8654-6ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
68788-8654-9ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8654-3EA - Each68788-865444adb2c3-0884-4f77-9844-97cabe62654d12024-06-10
68788-8654-6EA - Each68788-8654cf38b865-25d5-43e1-8fbf-417da1ac8b9712024-06-10
68788-8654-9EA - Each68788-8654bf850e70-9810-47aa-9c2c-08477815a32d12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8654ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240511_76ff87e4-3aa2-439d-8436-d9e6affb33c8.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepackbf99cd5c-9671-45a6-bda9-3dfc8252efdd2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy21767f56-ce92-2b8c-e063-6394a90a8b762026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.bca751bb-5161-5a95-e053-2a95a90aa2dd2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELupin Pharmaceuticals, Inc.ac647afe-2fe5-4056-806f-abdd54789b452025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.76ff87e4-3aa2-439d-8436-d9e6affb33c82025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ndc (package): 68788-8654-9
ndc (product): 68788-8654
ndc11 (package): 68788865409
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc..72e19b8e-d13a-4824-aee4-11778eba552c2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack028bf425-7a72-464d-a242-aa5deee1ac232025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.30c057fb-2e1b-4b9c-8c8a-79c322151e612025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXc3f23bc3-595b-28e5-e053-2a95a90a9c2c2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack604e77ef-2cda-4efc-abfb-9af549d40fd42024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1a8a8072-39bf-44c5-e063-6294a90a77c32024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC08411424-e8a8-4964-bd04-5b0b5aa5baaf2024-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEProficient Rx LPacf9f431-3013-4cfd-ba4d-c4013f20bdab2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078970
application number: ANDA078970

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN76ff87e4-3aa2-439d-8436-d9e6affb33c82
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD76ff87e4-3aa2-439d-8436-d9e6affb33c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8654-96878886540990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-9) 2024-05-09NoNoCurrent