Application 086988

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	750MG	No	No
002	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	500MG	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
A086988-001	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982
A086988-002	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086988-001	AA
A086988-002	AA

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 2 · 66 observed 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
2026-02-19 14:30 UTC	2026-02	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086988-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086988-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086988-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086988-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086988-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086988-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086988-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086988-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086988-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086988-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086988-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086988-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086988-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086988-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086988-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086988-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086988-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086988-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086988-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086988-001	AA	1	`b00525d2431f…`

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 application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 55154-2335
Methocarbamol	METHOCARBAMOL	Major Pharmaceuticals	2df34fa7-9cdc-4be4-ac6f-577122462606	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 0904-7058
Methocarbamol	METHOCARBAMOL	Solco Healthcare LLC	32863f21-30ff-4a8b-a2e6-8ab14a37af0d	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 43547-226
Methocarbamol	METHOCARBAMOL	REMEDYREPACK INC.	87ff444e-d502-428c-8be7-89d36c0cf709	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988
Methocarbamol	METHOCARBAMOL	Golden State Medical Supply, Inc.	c67d3e2b-92cd-1b97-e053-2a95a90af36f	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 51407-467 ndc (product): 51407-468
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	4003026f-ed9e-40ac-9e7e-5e28d32d7cb8	2023-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 71335-1727
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	b415184c-1603-4a86-92d2-746f8d3d3f3c	2023-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 63629-8995
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	27c39343-44e0-4ca6-a67f-1e6d11dd6799	2021-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 71610-598
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	0003eccd-6147-4a7c-ae83-b2a94933e07d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086988 application number: ANDA086988 ndc (product): 63187-130

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7058	Methocarbamol	Methocarbamol	Major Pharmaceuticals	ANDA	Current
0904-7058	Methocarbamol	Methocarbamol	Major Pharmaceuticals	ANDA	Current
0904-7058	Methocarbamol	Methocarbamol	Major Pharmaceuticals	ANDA	Current
10544-464	Methocarbamol	Methocarbamol	Blenheim Pharmacal, Inc.	ANDA	Current
43547-226	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-226	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-226	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-226	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
43547-226	Methocarbamol	Methocarbamol	Solco Healthcare LLC	ANDA	Current
45865-542	Methocarbamol	Methocarbamol	Medsource Pharmaceuticals	ANDA	Current
51407-467	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
51407-468	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
51407-468	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
51655-141	Methocarbamol	Methocarbamol	Northwind Pharmaceuticals, LLC	ANDA	Current
55154-2335	Methocarbamol	Methocarbamol	Cardinal Health	ANDA	Current
55154-2335	Methocarbamol	Methocarbamol	Cardinal Health 107, LLC	ANDA	Current
61919-147	Methocarbamol	Methocarbamol	Direct RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	Methocarbamol	Methocarbamol	Direct RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
61919-148	METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	ANDA	Current
63187-130	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
63187-130	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
63187-130	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
63629-1124	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1124	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1124	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1125	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1125	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1244	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-8995	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
68788-9768	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9768	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-1727	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71335-1727	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71610-598	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-598	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current