Application 078129

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET;ORAL	5MG	No	No
002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET;ORAL	10MG	No	No

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
A078129-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL			2008-04-30
A078129-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL			2008-04-30

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078129-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	2008-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078129-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	2008-04-30	`782e0a99824c…`

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 6 · 118 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	507225e2-80ba-18c4-e054-00144ff88e88	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	TORRENT PHARMACEUTICALS LIMITED	9025a6f7-5501-4aba-875e-222ef39848c0	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	90201886-86a5-4c59-a4f1-98270d620731	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	bf99cd5c-9671-45a6-bda9-3dfc8252efdd	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Torrent Pharmaceuticals Limited	1584bad1-7bf4-4805-bdd9-7eb0fac92721	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	89cfb1d5-437c-4c13-8f9b-b6851ffba87b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	cf3dcbde-b92a-4802-98e4-14f00abdf99e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	21767f56-ce92-2b8c-e063-6394a90a8b76	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Umedica Laboratories USA Inc.	b49f6c18-e155-4728-a79a-9354e8c3c8f4	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	0f8488f3-851d-4111-af23-60f420aad0d6	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	bca751bb-5161-5a95-e053-2a95a90aa2dd	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	2abdcf77-d3ed-42bc-acd9-545aab75d567	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	2556c804-7a5e-4dbd-aeef-a3ba3a247c39	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	f67ef513-1b2c-42fe-bf33-4c7e9db191a3	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Calvin Scott & Co., Inc.	7da75d2b-905c-4fdf-bc53-1358c6477755	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	59cc61da-838e-4add-b2d6-42b2b283a000	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Direct_Rx	907c7b18-2638-512c-e053-2995a90ae6fd	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	47212207-52a1-938b-e063-6294a90abca8	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9962	Zolpidem	Zolpidem Tartrate	West-ward Pharmaceutical Corp	ANDA	Current
0143-9962	Zolpidem	Zolpidem Tartrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9963	Zolpidem	Zolpidem Tartrate	West-ward Pharmaceutical Corp	ANDA	Current
0143-9963	Zolpidem	Zolpidem Tartrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23894	ORIG	2008-05-14