Home NDC 61919-528 ZOLPIDEM TARTRATE
Product NDC 61919-528
11-digit product format 619190528
Labeler code 61919
Product ID 61919-528_05a546cc-4ed6-4466-a288-63ee2e1193d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ZOLPIDEM TARTRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA078616
Marketing category ANDA
Marketing start 2014-01-01
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]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078616-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 A078616-002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21
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 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB 2008-11-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB 2008-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078616-001 ZOLPIDEM TARTRATE 5MG TABLET / ORAL 2008-11-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078616-002 ZOLPIDEM TARTRATE 10MG TABLET / ORAL 2008-11-21 782e0a99824c…
Observed Orange Book normalized TE history# 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 61919-528-20 ZOLPIDEM TARTRATE 20 in 1 BOTTLE TABLET, FILM COATED 20 4 61919-528-30 ZOLPIDEM TARTRATE 30 in 1 BOTTLE TABLET, FILM COATED 30 4 61919-528-60 ZOLPIDEM TARTRATE 60 in 1 BOTTLE TABLET, FILM COATED 60 4
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 [DIRECT RX] 4 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-528 ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] 4 Legacy NDC, 3 package rows 20151110_0ca400d2-4864-43de-bd2f-cda62eb0ab1e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 61919-528-20 61919052820 20 in 1 BOTTLE Historical 61919-528-30 61919052830 30 in 1 BOTTLE Historical 61919-528-60 61919052860 60 in 1 BOTTLE Historical