Home NDC 43353-620 Zolpidem Tartrate
Product NDC 43353-620
11-digit product format 433530620
Labeler code 43353
Product ID 43353-620_e3b4f606-6863-49a5-be7c-48d86b85bdaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078616
Marketing category ANDA
Marketing start 2008-11-21
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 2019-12-31
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 5 · 252 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# NDC, Related label table NDC Related label 43353-620-07 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-10 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-14 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-15 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-20 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-28 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-30 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-45 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-53 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-59 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992 43353-620-60 These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-620-07 Zolpidem Tartrate 7 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 7 2 43353-620-10 Zolpidem Tartrate 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 2 43353-620-14 Zolpidem Tartrate 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 2 43353-620-15 Zolpidem Tartrate 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 2 43353-620-20 Zolpidem Tartrate 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 2 43353-620-28 Zolpidem Tartrate 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 2 43353-620-30 Zolpidem Tartrate 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 43353-620-45 Zolpidem Tartrate 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 2 43353-620-53 Zolpidem Tartrate 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 43353-620-59 Zolpidem Tartrate 22 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 22 2 43353-620-60 Zolpidem Tartrate 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-620 ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 11 package rows 20140416_cace3d8a-cbb5-4072-9bce-28219b4909ae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-620-07 43353062007 7 in 1 BOTTLE, PLASTIC Historical 43353-620-10 43353062010 10 in 1 BOTTLE, PLASTIC Historical 43353-620-14 43353062014 14 in 1 BOTTLE, PLASTIC Historical 43353-620-15 43353062015 15 in 1 BOTTLE, PLASTIC Historical 43353-620-20 43353062020 20 in 1 BOTTLE, PLASTIC Historical 43353-620-28 43353062028 28 in 1 BOTTLE, PLASTIC Historical 43353-620-30 43353062030 30 in 1 BOTTLE, PLASTIC Historical 43353-620-45 43353062045 45 in 1 BOTTLE, PLASTIC Historical 43353-620-53 43353062053 60 in 1 BOTTLE, PLASTIC Historical 43353-620-59 43353062059 22 in 1 BOTTLE, PLASTIC Historical 43353-620-60 43353062060 90 in 1 BOTTLE, PLASTIC Historical