Application 077214

Type: ANDA
Sponsor: ACME LABS

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 43.

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
A077214-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-04-23
A077214-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077214-001	AB
A077214-002	AB

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A077214-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077214-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077214-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077214-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077214-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077214-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077214-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077214-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077214-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077214-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077214-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077214-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077214-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077214-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077214-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077214-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077214-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077214-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077214-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077214-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077214-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077214-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077214-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077214-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077214-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077214-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077214-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077214-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077214-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077214-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077214-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077214-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077214-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077214-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077214-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077214-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077214-002	AB	1	`f41ea6bd6efb…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	3882d72d-686b-406b-e063-6294a90a0b89	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	349053e4-9885-ec0b-e063-6294a90ad79a	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e15d6e3-8d06-0936-e063-6394a90ab8db	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e13ad50-f846-813a-e063-6294a90a5878	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8cef5718-c562-43c3-8abe-a2fc5235ad2a	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (product): 63629-8998
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	fff2e7fc-2f7e-43c9-bfb3-d929ecc9eb72	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (product): 63629-1170
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	74c4e793-3444-4d3d-8211-26374349ab1e	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	1fa86b79-8809-35f4-e063-6394a90a4377	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	1a8f7696-0d02-dd1f-e063-6394a90a5866	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	70d7cfc3-7e54-4cd8-8911-7cf115d5c820	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	23bce69d-7918-42c2-8020-e22f292ff31f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3aa7e88b-7929-45ac-9e81-03f4abf28e94	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (product): 63629-8999
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	1e5b61b6-a5bd-4f09-9d34-905ce32f1899	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	df130798-1458-455b-a4e1-c33c4ecee43b	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	33094305-4bbd-4b52-9079-8853d5f83682	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	ACI Healthcare USA, Inc	021153ce-fe27-4ed1-8d88-b4157b0ed734	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (product): 71093-156 ndc (product): 71093-155
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (product): 71610-670
Zolpidem	ZOLPIDEM TARTRATE	Proficient Rx LP	f76eb9d8-ca7d-4479-bd16-52a57f623b02	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (product): 71205-691

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0086	Zolpidem Tartrate	zolpidem tartrate	Roxane Laboratories, Inc	ANDA	Current
0054-0087	Zolpidem Tartrate	zolpidem tartrate	Roxane Laboratories, Inc	ANDA	Current
50436-0009	Zolpidem	Zolpidem Tartrate	Unit Dose Services	ANDA	Current
63629-1170	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-1170	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-1171	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-1171	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-1171	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-8998	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-8998	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-8999	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-8999	Zolpidem	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
68071-2642	Zolpidem	Zolpidem Tartrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2774	Zolpidem	Zolpidem Tartrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-917	Zolpidem	Zolpidem Tartrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71093-155	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-155	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-155	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-155	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-156	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-156	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-156	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71093-156	Zolpidem	Zolpidem Tartrate	ACI Healthcare USA, Inc	ANDA	Current
71205-691	Zolpidem	Zolpidem Tartrate	Proficient Rx LP	ANDA	Current
71610-670	Zolpidem	Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9018	ORIG	2007-05-01