Methocarbamol

Product NDC: 82804-955
11-digit product format: 828040955
Labeler code: 82804
Product ID: 82804-955_e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040489
Marketing category: ANDA
Marketing start: 2019-08-15
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 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
A040489-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2003-01-29
A040489-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2003-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040489-001	AA
A040489-002	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 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	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040489-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040489-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040489-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040489-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040489-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040489-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040489-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040489-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040489-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040489-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040489-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040489-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040489-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040489-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040489-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040489-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040489-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040489-002	AA	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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
e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	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	SPL version
82804-955-00	Methocarbamol	100 in 1 BOTTLE	TABLET	100	1
82804-955-30	Methocarbamol	30 in 1 BOTTLE	TABLET	30	1
82804-955-55	Methocarbamol	500 in 1 BOTTLE	TABLET	500	1
82804-955-60	Methocarbamol	60 in 1 BOTTLE	TABLET	60	1
82804-955-72	Methocarbamol	120 in 1 BOTTLE	TABLET	120	1
82804-955-90	Methocarbamol	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-955-00	EA - Each	82804-955	77860785-9b73-48ff-816f-2b1f0fd5333e	1	2026-02-05
82804-955-30	EA - Each	82804-955	0524505d-2482-4a0a-b120-86526ff97e68	1	2026-02-05
82804-955-55	EA - Each	82804-955	b072403c-4440-48dd-87ea-016b06d08d17	1	2026-02-05
82804-955-60	EA - Each	82804-955	7fb718ff-7b88-4bea-b972-4de94f44d09e	1	2026-02-05
82804-955-72	EA - Each	82804-955	b29e23f0-e67f-4884-8e63-c116a03ab96a	1	2026-02-05
82804-955-90	EA - Each	82804-955	6e34f52b-c91f-4c65-8f83-88ceb904e376	1	2026-02-05

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 3 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	47d8f1c7-8395-48e0-ac6f-d35dadfb7a50	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals, Inc.	1c368c79-ac60-bfa7-e063-6394a90a9ff7	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	5a9b1104-4c9a-4c8c-9e24-719a7b3a89d7	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Medsource Pharmaceuticals	127583d4-7963-bd6d-e063-6294a90ab73e	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	1637e18d-d9f9-4171-99e6-4b866d821c87	2024-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	2023-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	d8e3f8dc-9751-419b-8601-d85c43415c82	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489

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	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197944	methocarbamol 750 MG Oral Tablet	PSN	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197943	methocarbamol 500 MG Oral Tablet	SCD	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197944	methocarbamol 750 MG Oral Tablet	SCD	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-955-00	82804095500	100 TABLET in 1 BOTTLE (82804-955-00)	100 tablet	2026-01-12	No	No	Current
82804-955-30	82804095530	30 TABLET in 1 BOTTLE (82804-955-30)	30 tablet	2026-01-12	No	No	Current
82804-955-55	82804095555	500 TABLET in 1 BOTTLE (82804-955-55)	500 tablet	2026-01-12	No	No	Current
82804-955-60	82804095560	60 TABLET in 1 BOTTLE (82804-955-60)	60 tablet	2026-01-12	No	No	Current
82804-955-72	82804095572	120 TABLET in 1 BOTTLE (82804-955-72)	120 tablet	2026-01-12	No	No	Current
82804-955-90	82804095590	90 TABLET in 1 BOTTLE (82804-955-90)	90 tablet	2026-01-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1