Home NDC 55648-715 ZOLPIDEM TARTRATE
Product NDC 55648-715
11-digit product format 556480715
Labeler code 55648
Product ID 55648-715_1818aead-1bb7-45f5-88f2-4278bbccc8fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
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 E
Listing certified through 2018-12-31
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 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-715-01 ZOLPIDEM TARTRATE 100 in 1 BOTTLE TABLET, FILM COATED 100 2 55648-715-02 ZOLPIDEM TARTRATE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 55648-715-04 ZOLPIDEM TARTRATE 500 in 1 BOTTLE TABLET, FILM COATED 500 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZOLPIDEM TARTRATE ACTIVE INGREDIENT WY6W63843K ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM TARTRATE INACTIVE INGREDIENT 6GB0J700TG ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-715 ZOLPIDEM TARTRATE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 3 package rows 20121102_ab34bf06-cd41-41ae-b20b-73c5859b2fab.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-715-01 55648071501 100 in 1 BOTTLE Historical 55648-715-02 55648071502 1000 in 1 BOTTLE Historical 55648-715-04 55648071504 500 in 1 BOTTLE Historical