Home NDC 12634-943 ZOLPIDEM TARTRATE
Product NDC 12634-943
11-digit product format 126340943
Labeler code 12634
Product ID 12634-943_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ZOLPIDEM TARTRATE
Dosage form TABLET
Route ORAL
Labeler APOTHECA, INC
Application ANDA077884
Marketing category ANDA
Marketing start 2007-07-25
Marketing end 0000-00-00
Substance ZOLPIDEM TARTRATE
Active strength 5 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 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077884-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 A077884-002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23
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 · 88 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 2026-10-15 13:18:30 2026-09 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077884-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077884-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 74 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-943-00 ZOLPIDEM TARTRATE 10 in 1 BOTTLE TABLET 10 1 12634-943-71 ZOLPIDEM TARTRATE 30 in 1 BOTTLE TABLET 30 1 12634-943-91 ZOLPIDEM TARTRATE 1 in 1 BLISTER PACK TABLET 1 1 12634-943-95 ZOLPIDEM TARTRATE 5 in 1 BOTTLE TABLET 5 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZOLPIDEM TARTRATE ACTIVE INGREDIENT WY6W63843K ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 POLYVINYL ALCOHOl INACTIVE INGREDIENT 532B59J990 ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-943 ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] 1 Legacy NDC, 4 package rows 20131127_7638e2bd-04c5-4ad2-8635-fb460ab4d1c3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 12634-943-00 12634094300 10 in 1 BOTTLE Historical 12634-943-71 12634094371 30 in 1 BOTTLE Historical 12634-943-91 12634094391 1 in 1 BLISTER PACK Historical 12634-943-95 12634094395 5 in 1 BOTTLE Historical