ZOLPIDEM TARTRATE

Product NDC
50090-5804
11-digit product format
500905804
Labeler code
50090
Product ID
50090-5804_1f6ac937-6707-4d59-846e-532afcfd45d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
A077903-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17
A077903-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077903-001AB
A077903-002AB

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 UTC2026-02A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17782e0a99824c…

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 UTC2026-02A077903-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077903-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077903-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077903-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077903-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077903-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077903-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077903-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077903-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077903-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077903-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077903-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077903-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077903-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077903-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077903-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077903-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077903-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE10 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
854873Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e68a1b3b-b3d1-495e-be46-466113e7dbd6Available 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
50090-5804-0ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5804-0EA - Each50090-5804ae004da7-57dd-4833-98e6-a7b93101367612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5804ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230915_e68a1b3b-b3d1-495e-be46-466113e7dbd6.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy507225e2-80ba-18c4-e054-00144ff88e882026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy89cfb1d5-437c-4c13-8f9b-b6851ffba87b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEREMEDYREPACK INC.2abdcf77-d3ed-42bc-acd9-545aab75d5672026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECalvin Scott & Co., Inc.7da75d2b-905c-4fdf-bc53-1358c64777552026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirect_Rx907c7b18-2638-512c-e053-2995a90ae6fd2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENorthwind Health Company, LLC26e20f53-c042-eac0-e063-6394a90acfca2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECardinal Health 107, LLC83510333-f07d-4b81-a3ae-2801d114bd312025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc.a9ac3d4e-f502-41e3-95c0-0d334584566d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEMajor Pharmaceuticalsd34336b1-7041-4078-beda-94bc9d9f771e2025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.e5e2d31b-ce26-78b0-e053-2a95a90ac4912025-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87ae17-a3c5-a3a5-e053-2a95a90aa4b02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc8adec28-9dcd-4a7e-e053-2a95a90a991e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCf939549f-14a6-d37c-e053-6294a90a034a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLCdb735db9-1c82-4d32-bf91-97b05a75e8762024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.95b0ba48-4e71-25f7-e053-2a95a90aea822024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack413b6f65-101e-e2cf-0802-711d080b851b2024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack3bbc3c35-2811-4a67-9dcc-5eed38ef8b522024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNe68a1b3b-b3d1-495e-be46-466113e7dbd61
854873zolpidem tartrate 10 MG Oral TabletSCDe68a1b3b-b3d1-495e-be46-466113e7dbd61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-5804-05009058040090 TABLET in 1 BOTTLE (50090-5804-0) 90 tablet2021-10-15NoNoCurrent