Methocarbamol

Product NDC: 0904-7058
11-digit product format: 009047058
Labeler code: 0904
Product ID: 0904-7058_c3494126-0814-49ac-818e-54bee8f6b4a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA086988
Marketing category: ANDA
Marketing start: 2013-01-15
Substance: METHOCARBAMOL
Active strength: 750 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methocarbamol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOCARBAMOL	750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
125OD7737X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197943	Internal RxNorm lookup
197944	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2df34fa7-9cdc-4be4-ac6f-577122462606	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
492965be-47bc-38cf-57c4-5c5e0343abe5	Product name	6	20211028
02a01e9c-3f4e-c0ee-6542-be865127aea3	Product name	8	20190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7058-61	Methocarbamol	1 in 1 BLISTER PACK	TABLET	1		9
0904-7058-61	Methocarbamol	100 in 1 CARTON	TABLET	100		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7058	METHOCARBAMOL TABLET [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 2 package rows	20250223_2df34fa7-9cdc-4be4-ac6f-577122462606.zip

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
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
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
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
125OD7737X	METHOCARBAMOL	532-03-6	METHOCARBAMOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197943	methocarbamol 500 MG Oral Tablet	PSN	2df34fa7-9cdc-4be4-ac6f-577122462606	9
197944	methocarbamol 750 MG Oral Tablet	PSN	2df34fa7-9cdc-4be4-ac6f-577122462606	9
197943	methocarbamol 500 MG Oral Tablet	SCD	2df34fa7-9cdc-4be4-ac6f-577122462606	9
197944	methocarbamol 750 MG Oral Tablet	SCD	2df34fa7-9cdc-4be4-ac6f-577122462606	9
197943	methocarbamol 500 MG Oral Tablet	PSN	50603730-9f69-4ed7-bccf-31c474f83e14	8
197944	methocarbamol 750 MG Oral Tablet	PSN	50603730-9f69-4ed7-bccf-31c474f83e14	8
197943	methocarbamol 500 MG Oral Tablet	SCD	50603730-9f69-4ed7-bccf-31c474f83e14	8
197944	methocarbamol 750 MG Oral Tablet	SCD	50603730-9f69-4ed7-bccf-31c474f83e14	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7058-61	00904705861	100 BLISTER PACK in 1 CARTON (0904-7058-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2013-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP	Cardinal Health 107, LLC	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	9
Methocarbamol Tablets, USP	Major Pharmaceuticals	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	9