Home NDC 0024-5421 Ambien
Product NDC 0024-5421
11-digit product format 000245421
Labeler code 0024
Product ID 0024-5421_3d6feaca-4f30-4ca9-a9c8-d9038744fa2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sanofi-Aventis U.S. LLC
Application NDA019908
Marketing category NDA
Marketing start 1993-04-01
Marketing end 2026-09-30
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
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019908-001 AMBIEN ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB RLD 1992-12-16 N019908-002 AMBIEN ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB RLD, RS 1992-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ambien Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLPIDEM TARTRATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WY6W63843K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854873 Internal RxNorm lookup 854875 Internal RxNorm lookup 854876 Internal RxNorm lookup 854878 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0024-5421-31 2024-08-20 These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992 0024-5421-50 2024-08-20 These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992 0024-5421-31 2024-07-30 These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992 0024-5421-50 2024-07-30 These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992 0024-5421-31 2024-01-30 These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992 0024-5421-50 2024-01-30 These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0024-5421-31 Ambien 100 in 1 BOTTLE TABLET, FILM COATED 100 26 0024-5421-50 Ambien 500 in 1 BOTTLE TABLET, FILM COATED 500 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded zolpidem tartrate ACTIVE INGREDIENT WY6W63843K AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 zolpidem ACTIVE MOIETY 7K383OQI23 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 lactose INACTIVE INGREDIENT J2B2A4N98G AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 10 ZOLPIDEM TARTRATE ACTIVE INGREDIENT WY6W63843K AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 LACTOSE INACTIVE INGREDIENT J2B2A4N98G AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC] 3 zolpidem tartrate ACTIVE INGREDIENT WY6W63843K AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 zolpidem ACTIVE MOIETY 7K383OQI23 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 hypromellose INACTIVE INGREDIENT 3NXW29V3WO AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 lactose INACTIVE INGREDIENT J2B2A4N98G AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-5421 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 26 Current NDC, Legacy NDC, 2 package rows 20250418_c36cadf4-65a4-4466-b409-c82020b42452.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0024-5421-31 00024542131 100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31) 1993-04-01 2026-09-30 No No Current 0024-5421-50 00024542150 500 in 1 BOTTLE Historical