Zolpidem

Product NDC
63629-1171
11-digit product format
636291171
Labeler code
63629
Product ID
63629-1171_a58208e0-4109-4abb-a9eb-696669aa7081
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
A077214-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23
A077214-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077214-001AB
A077214-002AB

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 UTC2026-02A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23782e0a99824c…

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 UTC2026-02A077214-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077214-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077214-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077214-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077214-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077214-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077214-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077214-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077214-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077214-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077214-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077214-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077214-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077214-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077214-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077214-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077214-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077214-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Zolpidem
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
c6824c69-76bc-4ca0-a6b1-5cddc2c42fc9Available 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
63629-1171-1Zolpidem100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1171ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 1 package rows20240514_c6824c69-76bc-4ca0-a6b1-5cddc2c42fc9.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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEGolden State Medical Supply, Inc.2b5cf535-ccdc-ecd7-e063-6394a90a726e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEThe ACME Laboratories Ltd.5679ed64-8424-4e63-a3c9-91d80fff2ca62026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC3882d72d-686b-406b-e063-6294a90a0b892025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC349053e4-9885-ec0b-e063-6294a90ad79a2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e15d6e3-8d06-0936-e063-6394a90ab8db2025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e13ad50-f846-813a-e063-6294a90a58782024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack8cef5718-c562-43c3-8abe-a2fc5235ad2a2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackfff2e7fc-2f7e-43c9-bfb3-d929ecc9eb722024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack74c4e793-3444-4d3d-8211-26374349ab1e2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC1fa86b79-8809-35f4-e063-6394a90a43772024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEGolden State Medical Supply, Inc.1a8f7696-0d02-dd1f-e063-6394a90a58662024-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack70d7cfc3-7e54-4cd8-8911-7cf115d5c8202024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack23bce69d-7918-42c2-8020-e22f292ff31f2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack3aa7e88b-7929-45ac-9e81-03f4abf28e942024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack1e5b61b6-a5bd-4f09-9d34-905ce32f18992024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackc6824c69-76bc-4ca0-a6b1-5cddc2c42fc92024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 63629-1171
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackdf130798-1458-455b-a4e1-c33c4ecee43b2023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack33094305-4bbd-4b52-9079-8853d5f836822023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEACI Healthcare USA, Inc021153ce-fe27-4ed1-8d88-b4157b0ed7342023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC8581cfad-525b-4b16-b116-a5138d9fda522022-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNc6824c69-76bc-4ca0-a6b1-5cddc2c42fc97
854873zolpidem tartrate 10 MG Oral TabletSCDc6824c69-76bc-4ca0-a6b1-5cddc2c42fc97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1171-163629117101100 TABLET in 1 BOTTLE (63629-1171-1) 100 tablet2020-09-240000-00-00NoNoCurrent