Application 040734

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHIMAZOLE	METHIMAZOLE	TABLET;ORAL	5MG	No	No
002	METHIMAZOLE	METHIMAZOLE	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
A040734-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB		2007-12-14
A040734-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB		2007-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040734-001	AB
A040734-002	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	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`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	A040734-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040734-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040734-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040734-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040734-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040734-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040734-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040734-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040734-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040734-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040734-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040734-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040734-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040734-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040734-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040734-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040734-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040734-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040734-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040734-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040734-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040734-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040734-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040734-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040734-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040734-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040734-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040734-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040734-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040734-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040734-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040734-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040734-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040734-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040734-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040734-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040734-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040734-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040734-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040734-002	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 70518-1475
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	b53f84ac-4263-478c-883d-aca7ab44fef5	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 70518-1506
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	c1e6f1ee-238c-466e-b223-3c3f63dac9ed	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 68788-8226
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	244d76f1-98e6-4305-8768-b104f6a4be07	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 68788-8227
Methimazole	METHIMAZOLE	Proficient Rx LP	e921f23b-a9bf-4313-9cfa-f0b29c06f72a	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Golden State Medical Supply, Inc.	4eff3321-2fce-4bab-94af-7b16e333beed	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 60429-381 ndc (product): 60429-380
Methimazole	METHIMAZOLE	NORTHSTAR RX LLC	923fec30-90fd-4bd5-beb3-f2ca4fc171ee	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	381052c4-891c-4ae4-b63e-65229126cbca	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 71335-0883
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	3ca961ca-cbf2-4a73-8c81-4205e01b2695	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 63629-8347
Methimazole	METHIMAZOLE	A-S Medication Solutions	87eb663e-5dd3-4a7a-8b28-7e19c5ad1173	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8c3a9aaa-cdde-404b-9af6-5a88ef649aac	2022-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734 ndc (product): 23155-071 ndc (product): 23155-070

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 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-070	Methimazole	Methimazole	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-070	Methimazole	Methimazole	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-070	Methimazole	Methimazole	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-071	Methimazole	Methimazole	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-071	Methimazole	Methimazole	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-071	Methimazole	Methimazole	Heritage Pharmaceuticals Inc.	ANDA	Current
53808-0949	Methimazole	Methimazole	State of Florida DOH Central Pharmacy	ANDA	Current
60429-380	Methimazole	Methimazole	Golden State Medical Supply Inc.	ANDA	Current
60429-380	Methimazole	Methimazole	Golden State Medical Supply	ANDA	Current
60429-380	Methimazole	Methimazole	Golden State Medical Supply	ANDA	Current
60429-381	Methimazole	Methimazole	Golden State Medical Supply Inc.	ANDA	Current
60429-381	Methimazole	Methimazole	Golden State Medical Supply	ANDA	Current
60429-381	Methimazole	Methimazole	Golden State Medical Supply	ANDA	Current
60429-381	Methimazole	Methimazole	Golden State Medical Supply, Inc.	ANDA	Current
63629-8347	Methimazole	Methimazole	Bryant Ranch Prepack	ANDA	Current
63629-8347	Methimazole	Methimazole	Bryant Ranch Prepack	ANDA	Current
66336-623	Methimazole	Methimazole	Dispensing Solutions, Inc.	ANDA	Current
68071-3027	Methimazole	Methimazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5197	Methimazole	Methimazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5197	Methimazole	Methimazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8226	Methimazole	Methimazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8227	Methimazole	Methimazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8926	Methimazole	Methimazole	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1475	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1475	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1475	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1475	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1475	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1475	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70518-1506	Methimazole	Methimazole	REMEDYREPACK INC.	ANDA	Current
70934-478	Methimazole	Methimazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0883	Methimazole	Methimazole	Bryant Ranch Prepack	ANDA	Current
71335-0883	Methimazole	Methimazole	Bryant Ranch Prepack	ANDA	Current
71335-0883	Methimazole	Methimazole	Bryant Ranch Prepack	ANDA	Current
71335-0883	Methimazole	Methimazole	Bryant Ranch Prepack	ANDA	Current