Methocarbamol

Product NDC: 50090-5008
11-digit product format: 500905008
Labeler code: 50090
Product ID: 50090-5008_d6c42c6b-60db-423c-8f89-0ab8ccf390bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
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 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A040489-001	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040489-002	AA	1	`c2088c7a36db…`
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…`

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5008-0	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-1	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-2	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-3	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-4	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-6	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-7	2023-02-07	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-0	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-1	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-2	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-3	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-4	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-6	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
50090-5008-7	2023-01-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5008-0	Methocarbamol	20 in 1 BOTTLE	TABLET	20	5
50090-5008-1	Methocarbamol	40 in 1 BOTTLE	TABLET	40	5
50090-5008-2	Methocarbamol	28 in 1 BOTTLE	TABLET	28	5
50090-5008-3	Methocarbamol	30 in 1 BOTTLE	TABLET	30	5
50090-5008-4	Methocarbamol	60 in 1 BOTTLE	TABLET	60	5
50090-5008-6	Methocarbamol	100 in 1 BOTTLE	TABLET	100	5
50090-5008-7	Methocarbamol	12 in 1 BOTTLE	TABLET	12	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5008-0	EA - Each	50090-5008	eb1bbf65-7854-482a-a984-f2b6f7609ae4	1	2022-12-07
50090-5008-1	EA - Each	50090-5008	f9a412ac-aaf1-40c6-99fd-19eecbace9ef	1	2022-12-07
50090-5008-2	EA - Each	50090-5008	3ed133e9-08ae-4d67-b493-aee3e7fc38e4	1	2022-12-07
50090-5008-3	EA - Each	50090-5008	bff20f9f-2710-4d58-b5ab-6da456ee4af6	1	2021-08-05
50090-5008-4	EA - Each	50090-5008	2668e42b-6841-43a3-b26a-a267191f638d	1	2022-12-07
50090-5008-6	EA - Each	50090-5008	f8dea446-4570-4e5c-a7e2-3881816b574b	1	2022-12-07
50090-5008-7	EA - Each	50090-5008	be173c78-6476-40ee-b001-a11737a1e127	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5008	METHOCARBAMOL TABLET [A-S MEDICATION SOLUTIONS]	5	Current NDC, Legacy NDC, 7 package rows	20230208_d217bd1d-0b6e-4a4c-a47b-de73b94e8b13.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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 50090-5008

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
197944	methocarbamol 750 MG Oral Tablet	PSN	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	5
197944	methocarbamol 750 MG Oral Tablet	SCD	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5008-0	50090500800	20 TABLET in 1 BOTTLE (50090-5008-0)	20 tablet	2020-04-15	0000-00-00	No	No	Current
50090-5008-1	50090500801	40 TABLET in 1 BOTTLE (50090-5008-1)	40 tablet	2020-04-15	0000-00-00	No	No	Current
50090-5008-2	50090500802	28 TABLET in 1 BOTTLE (50090-5008-2)	28 tablet	2020-04-15	0000-00-00	No	No	Current
50090-5008-3	50090500803	30 TABLET in 1 BOTTLE (50090-5008-3)	30 tablet	2020-04-15	0000-00-00	No	No	Current
50090-5008-4	50090500804	60 TABLET in 1 BOTTLE (50090-5008-4)	60 tablet	2020-04-15	0000-00-00	No	No	Current
50090-5008-6	50090500806	100 TABLET in 1 BOTTLE (50090-5008-6)	100 tablet	2020-04-15	0000-00-00	No	No	Current
50090-5008-7	50090500807	12 TABLET in 1 BOTTLE (50090-5008-7)	12 tablet	2020-04-15	0000-00-00	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	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	5