ZOLPIDEM TARTRATE

Product NDC
60760-819
Requested package NDC
60760-819-30
11-digit product format
607600819
Labeler code
60760
Product ID
60760-819_21769110-885f-a30e-e063-6394a90a207c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078970
Marketing category
ANDA
Marketing start
2014-04-11
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 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 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
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 · 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 UTC2026-02A078970-001ZOLPIDEM 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…
2022-03-09 01:35 UTC2022-03A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078970-001ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A078970-002ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2013-09-11782e0a99824c…

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 UTC2026-02A078970-001AB1011fe1cb6892…
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…
2022-03-09 01:35 UTC2022-03A078970-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078970-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078970-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078970-002AB1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 60760-819-30
ndc (product): 60760-819
ndc11 (package): 60760081930
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2027-12-31

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
21767f56-ce92-2b8c-e063-6394a90a8b76Available 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
60760-819-30ZOLPIDEM TARTRATE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-819-30EA - Each60760-8191ca607c7-eace-4d13-8bf7-79b04396759612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-819ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20240907_21767f56-ce92-2b8c-e063-6394a90a8b76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN21767f56-ce92-2b8c-e063-6394a90a8b761
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD21767f56-ce92-2b8c-e063-6394a90a8b761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-819-306076008193030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-819-30) 2024-08-28NoNoCurrent