Home NDC 0093-0073-01 Zolpidem Tartrate
Product NDC 0093-0073
Requested package NDC 0093-0073-01
11-digit product format 000930073
Labeler code 0093
Product ID 0093-0073_2d5139eb-e369-43f7-951b-666cf006ba33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolpidem Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076410
Marketing category ANDA
Marketing start 2007-04-23
Marketing end 0000-00-00
Substance ZOLPIDEM TARTRATE
Active strength 5 mg/1
Pharmacologic classes Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076410-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2007-04-23 A076410-002 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 · 82 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 2026-02-19 14:30 UTC 2026-02 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076410-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2007-04-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076410-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2007-04-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
DailyMed Product Concepts# 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 [TEVA PHARMACEUTICALS USA INC] 10 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-0073 ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 22 Legacy NDC 20250226_c784cf9d-de8f-44b6-b52f-a0e7c0d35e48.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-0073-01 00093007301 100 TABLET, FILM COATED in 1 BOTTLE (0093-0073-01) 2007-04-23 0000-00-00 No No Current