Home NDC 55111-478-05 Zolpidem Tartrate
Product NDC 55111-478
Requested package NDC 55111-478-05
11-digit product format 551110478
Labeler code 55111
Product ID 55111-478_ecc66592-aecd-1565-14b5-c0bc80ee8772
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolpidem Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA077985
Marketing category ANDA
Marketing start 2007-04-23
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 2020-12-31
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 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 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 A077985-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 A077985-002 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 · 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 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077985-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077985-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [DR. REDDY'S LABORATORIES LIMITED] 3 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55111-478-05 55111047805 500 TABLET, FILM COATED in 1 BOTTLE (55111-478-05) 2007-04-23 0000-00-00 No No Current