Home NDC 63304-160 Zolpidem Tartrate
Product NDC 63304-160
11-digit product format 633040160
Labeler code 63304
Product ID 63304-160_19edc487-123b-4cf4-8233-7b79438b6ae7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolpidem Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA078055
Marketing category ANDA
Marketing start 2007-04-23
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 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 A078055-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 A078055-002 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 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078055-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078055-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2007-04-23 4b0b4de00fa7…
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 63304-160-03 Zolpidem Tartrate 10 in 1 BOTTLE TABLET, FILM COATED 10 3 63304-160-10 Zolpidem Tartrate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3 63304-160-77 Zolpidem Tartrate 100 in 1 BLISTER PACK TABLET, FILM COATED 100 3
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 [RANBAXY PHARMACEUTICALS INC.] 3 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-160 ZOLPIDEM TARTRATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 Legacy NDC, 3 package rows 20150528_f5962f3a-a693-4f5f-b2ec-25c298f375c0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-160-03 63304016003 10 in 1 BOTTLE Historical 63304-160-10 63304016010 1000 in 1 BOTTLE Historical 63304-160-77 63304016077 100 in 1 BLISTER PACK Historical