Home NDC 64679-715 ZOLPIDEM TARTRATE
Product NDC 64679-715
11-digit product format 646790715
Labeler code 64679
Product ID 64679-715_c412b3cc-0a2c-491f-8dfd-d81a76770928
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA078426
Marketing category ANDA
Marketing start 2007-05-15
Marketing end 0000-00-00
Substance ZOLPIDEM TARTRATE
Active strength 10 mg/1
Pharmacologic classes gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-715-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-715-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-715-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-715-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-715-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-715-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-715-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-715-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-715-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-715-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-715-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-715-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-715-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-715-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-715-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-715-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-715-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-715-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-715-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-715-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-715-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-715-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-715-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-715-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-715-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-715-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-715-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-715-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-715-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-715-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-715-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-715-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-715-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-715-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-715-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-715-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64679-715-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64679-715-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64679-715-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64679-715-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64679-715-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64679-715-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64679-715-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64679-715-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64679-715-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078426-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 A078426-002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078426-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-05-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078426-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-05-15 74a2ff9319b5…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A078426-001 AB 1 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A078426-002 AB 1 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-715-01 2024-11-13 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM tartrate tablets, for oral use, C-IV Initial U.S. Approval : 1992 64679-715-02 2024-11-13 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM tartrate tablets, for oral use, C-IV Initial U.S. Approval : 1992 64679-715-04 2024-11-13 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM tartrate tablets, for oral use, C-IV Initial U.S. Approval : 1992 64679-715-01 2020-01-31 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM tartrate tablets, for oral use, C-IV Initial U.S. Approval : 1992 64679-715-02 2020-01-31 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM tartrate tablets, for oral use, C-IV Initial U.S. Approval : 1992 64679-715-04 2020-01-31 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM tartrate tablets, for oral use, C-IV Initial U.S. Approval : 1992
DailyMed Socrata Ingredients# DailyMed RxNorm Mappings#