Application 086989

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086989-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086989-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086989-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086989-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086989-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086989-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086989-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086989-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086989-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086989-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086989-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086989-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086989-001	AA	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A086989-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086989-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086989-001	AA	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Cardinal Health 107, LLC	50603730-9f69-4ed7-bccf-31c474f83e14	2026-06-05	Warnings, Adverse reactions	Exact identifier ndc (product): 55154-2334
Methocarbamol	METHOCARBAMOL	Major Pharmaceuticals	2df34fa7-9cdc-4be4-ac6f-577122462606	2026-02-10	Warnings, Adverse reactions	Exact identifier ndc (product): 0904-7057
Methocarbamol	METHOCARBAMOL	Solco Healthcare LLC	32863f21-30ff-4a8b-a2e6-8ab14a37af0d	2025-09-25	Warnings, Adverse reactions	Exact identifier ndc (product): 43547-405
Methocarbamol	METHOCARBAMOL	Golden State Medical Supply, Inc.	c67d3e2b-92cd-1b97-e053-2a95a90af36f	2025-06-10	Warnings, Adverse reactions	Exact identifier ndc (product): 51407-467
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	43ea5baa-4200-47ff-8819-44c802cba977	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989 ndc (product): 63629-1123
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	8cf27774-82ed-4ed1-a55d-41bf476745db	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	f1bce76f-4c3a-40d2-8107-afc0d3a6ba19	2023-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989 ndc (product): 71335-1795
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	27c39343-44e0-4ca6-a67f-1e6d11dd6799	2021-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989 ndc (product): 71610-599
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	75b964b7-3e76-4460-9777-7656b5daa32e	2020-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989 ndc (product): 71205-375

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7057	Methocarbamol	Methocarbamol	Major Pharmaceuticals	ANDA	Current
0904-7057	Methocarbamol	Methocarbamol	Major Pharmaceuticals	ANDA	Current
0904-7057	Methocarbamol	Methocarbamol	Major Pharmaceuticals	ANDA	Current
10544-773	Methocarbamol	Methocarbamol	Blenheim Pharmacal, Inc.	ANDA	Current
43547-405	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-405	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-405	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-405	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-405	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
51407-467	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
55154-2334	Methocarbamol	Methocarbamol	Cardinal Health	ANDA	Current
55154-2334	Methocarbamol	Methocarbamol	Cardinal Health 107, LLC	ANDA	Current
63629-1122	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1123	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1123	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-8984	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
68788-9388	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9388	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-375	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
71205-375	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
71335-1795	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71610-599	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-599	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current