Home NDC 10544-540 Zolpidem Tartrate
Product NDC 10544-540
11-digit product format 105440540
Labeler code 10544
Product ID 10544-540_11a76fc1-5a20-0509-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA078616
Marketing category ANDA
Marketing start 2013-10-03
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 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 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-540-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-540-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-540-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-540-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-540-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-540-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-540-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-540-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-540-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-540-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-540-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-540-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-540-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-540-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-540-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-540-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-540-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-540-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-540-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-540-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-540-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-540-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 10544-540-30 Zolpidem Tartrate 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1
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 [BLENHEIM PHARMACAL, INC.] 1 ZOLPIDEM ACTIVE MOIETY 7K383OQI23 ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-540 ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20150319_11a7a0c7-d5c6-0839-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-540-30 10544054030 30 in 1 BOTTLE, PLASTIC Historical