Methocarbamol

Product NDC: 69584-612
11-digit product format: 695840612
Labeler code: 69584
Product ID: 69584-612_869612eb-80c5-498d-b4c1-a4f26e93a542
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Oxford Pharmaceuticals, LLC
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69584-612	69584-612-01	D	Discontinued by firm		2026-08-03

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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2003-01-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2003-01-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040489-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040489-002	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3d4a2486-863e-4e9f-be3b-67882863e7d4	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6b9ed3a4-46d5-462e-ac93-6b959b314d77	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	adb49cb7-8900-44dc-add0-22e2cd8235ac	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	0deb5368-ffdc-40fc-a97c-ba89b7a97e50	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9617e2b0-4255-4542-95ca-9ee1818ca450	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	8643032a-c491-4ae4-ac46-5e0c4c79dc5b	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	cfdc0d68-00ad-44d6-b932-819cc3d5d60e	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	b81a8e64-ae41-409b-94a6-b36cb50bc25d	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	c4744824-4c74-411d-aa8e-c63ee9d89913	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	4ef1c2c0-31e1-4f85-b645-ff47a057a994	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals, Inc	425abc3b-2111-4fac-bf27-b685d1e657af	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Direct_rx	4c5c8933-a4b5-f9c2-e063-6294a90a6f00	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	5af36a83-2b36-4fe2-8c6a-61b551621421	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	cc004f5c-d5fc-48c5-9f37-c59b9c37e113	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	9076b4ad-17be-4933-a975-7bf80cc92b49	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	3f8aed5d-ba8d-4c32-872b-08ab15240cc1	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	St. Mary's Medical Park Pharmacy	fd8cac57-9664-1fa0-e053-6294a90af872	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	6466438c-4609-4554-8919-35710a1b556d	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	33f89a57-f65d-4e99-a3a3-690ef805d869	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	6af87b4e-6507-4190-b043-a6d3b440314a	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489

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
06dc72a6-ef3a-425a-9194-a9d228093cc4	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
69584-612-01	Methocarbamol	10 in 1 BOTTLE	TABLET	10	5
69584-612-09	Methocarbamol	90 in 1 BOTTLE	TABLET	90	5
69584-612-10	Methocarbamol	100 in 1 BOTTLE	TABLET	100	5
69584-612-50	Methocarbamol	500 in 1 BOTTLE	TABLET	500	5
69584-612-90	Methocarbamol	1000 in 1 BOTTLE	TABLET	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69584-612-10	EA - Each	69584-612	8c85fe67-c78f-4396-8604-4cb5ef44745a	1	2019-10-07
69584-612-50	EA - Each	69584-612	adf3f471-459a-48c3-86fa-d0e7aa2b7464	1	2019-10-07
69584-612-90	EA - Each	69584-612	da9f17a3-72c7-4045-b9cc-62a1a04b7b56	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69584-612	METHOCARBAMOL TABLET [OXFORD PHARMACEUTICALS, LLC]	4	Current NDC, Legacy NDC, 5 package rows	20240308_06dc72a6-ef3a-425a-9194-a9d228093cc4.zip

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	8c18ffef-b2c5-4af2-af66-e22c168e7680	106
197944	methocarbamol 750 MG Oral Tablet	SCD	8c18ffef-b2c5-4af2-af66-e22c168e7680	106
197944	methocarbamol 750 MG Oral Tablet	PSN	33f89a57-f65d-4e99-a3a3-690ef805d869	105
197944	methocarbamol 750 MG Oral Tablet	SCD	33f89a57-f65d-4e99-a3a3-690ef805d869	105
197944	methocarbamol 750 MG Oral Tablet	PSN	3f8aed5d-ba8d-4c32-872b-08ab15240cc1	102
197944	methocarbamol 750 MG Oral Tablet	PSN	cc004f5c-d5fc-48c5-9f37-c59b9c37e113	102
197944	methocarbamol 750 MG Oral Tablet	SCD	3f8aed5d-ba8d-4c32-872b-08ab15240cc1	102
197944	methocarbamol 750 MG Oral Tablet	SCD	cc004f5c-d5fc-48c5-9f37-c59b9c37e113	102
197944	methocarbamol 750 MG Oral Tablet	PSN	adb49cb7-8900-44dc-add0-22e2cd8235ac	8
197944	methocarbamol 750 MG Oral Tablet	SCD	adb49cb7-8900-44dc-add0-22e2cd8235ac	8
197944	methocarbamol 750 MG Oral Tablet	PSN	3d4a2486-863e-4e9f-be3b-67882863e7d4	7
197944	methocarbamol 750 MG Oral Tablet	PSN	afc9d84d-c8dd-05c0-e053-2a95a90a22a2	7
197944	methocarbamol 750 MG Oral Tablet	SCD	3d4a2486-863e-4e9f-be3b-67882863e7d4	7
197944	methocarbamol 750 MG Oral Tablet	SCD	afc9d84d-c8dd-05c0-e053-2a95a90a22a2	7
197944	methocarbamol 750 MG Oral Tablet	PSN	d8e3f8dc-9751-419b-8601-d85c43415c82	6
197944	methocarbamol 750 MG Oral Tablet	SCD	d8e3f8dc-9751-419b-8601-d85c43415c82	6
197943	methocarbamol 500 MG Oral Tablet	PSN	06dc72a6-ef3a-425a-9194-a9d228093cc4	5
197944	methocarbamol 750 MG Oral Tablet	PSN	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	5
197944	methocarbamol 750 MG Oral Tablet	PSN	4ef1c2c0-31e1-4f85-b645-ff47a057a994	5
197944	methocarbamol 750 MG Oral Tablet	PSN	06dc72a6-ef3a-425a-9194-a9d228093cc4	5
197943	methocarbamol 500 MG Oral Tablet	SCD	06dc72a6-ef3a-425a-9194-a9d228093cc4	5
197944	methocarbamol 750 MG Oral Tablet	SCD	06dc72a6-ef3a-425a-9194-a9d228093cc4	5
197944	methocarbamol 750 MG Oral Tablet	SCD	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	5
197944	methocarbamol 750 MG Oral Tablet	SCD	4ef1c2c0-31e1-4f85-b645-ff47a057a994	5
197944	methocarbamol 750 MG Oral Tablet	PSN	fd8cac57-9664-1fa0-e053-6294a90af872	3
197944	methocarbamol 750 MG Oral Tablet	PSN	5a9b1104-4c9a-4c8c-9e24-719a7b3a89d7	3
197944	methocarbamol 750 MG Oral Tablet	SCD	fd8cac57-9664-1fa0-e053-6294a90af872	3
197944	methocarbamol 750 MG Oral Tablet	SCD	5a9b1104-4c9a-4c8c-9e24-719a7b3a89d7	3
197944	methocarbamol 750 MG Oral Tablet	PSN	cff9b44c-618c-4beb-e053-2a95a90a24b0	2
197944	methocarbamol 750 MG Oral Tablet	PSN	f40f77aa-7bd3-4899-e053-2995a90a8486	2
197944	methocarbamol 750 MG Oral Tablet	SCD	cff9b44c-618c-4beb-e053-2a95a90a24b0	2
197944	methocarbamol 750 MG Oral Tablet	SCD	f40f77aa-7bd3-4899-e053-2995a90a8486	2
197943	methocarbamol 500 MG Oral Tablet	PSN	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	1
197943	methocarbamol 500 MG Oral Tablet	PSN	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197944	methocarbamol 750 MG Oral Tablet	PSN	ca5153da-e921-0bc4-e053-2995a90ac6aa	1
197944	methocarbamol 750 MG Oral Tablet	PSN	ca5060d8-4d38-7c19-e053-2995a90a3bdb	1
197944	methocarbamol 750 MG Oral Tablet	PSN	2cf76cdc-820d-1c5b-e063-6294a90a35aa	1
197944	methocarbamol 750 MG Oral Tablet	PSN	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197944	methocarbamol 750 MG Oral Tablet	PSN	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	1
197943	methocarbamol 500 MG Oral Tablet	SCD	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197943	methocarbamol 500 MG Oral Tablet	SCD	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	1
197944	methocarbamol 750 MG Oral Tablet	SCD	ca5153da-e921-0bc4-e053-2995a90ac6aa	1
197944	methocarbamol 750 MG Oral Tablet	SCD	2cf76cdc-820d-1c5b-e063-6294a90a35aa	1
197944	methocarbamol 750 MG Oral Tablet	SCD	ca5060d8-4d38-7c19-e053-2995a90a3bdb	1
197944	methocarbamol 750 MG Oral Tablet	SCD	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	1
197944	methocarbamol 750 MG Oral Tablet	SCD	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69584-612-01	69584061201	10 TABLET in 1 BOTTLE (69584-612-01)	10 tablet	2019-08-15	0000-00-00	No	No	Current
69584-612-09	69584061209	90 TABLET in 1 BOTTLE (69584-612-09)	90 tablet	2019-08-15	0000-00-00	No	No	Current
69584-612-10	69584061210	100 TABLET in 1 BOTTLE (69584-612-10)	100 tablet	2019-08-15	0000-00-00	No	No	Current
69584-612-50	69584061250	500 TABLET in 1 BOTTLE (69584-612-50)	500 tablet	2019-08-15	0000-00-00	No	No	Current
69584-612-90	69584061290	1000 TABLET in 1 BOTTLE (69584-612-90)	1000 tablet	2019-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP 750 mg Rx Only	PD-Rx Pharmaceuticals, Inc.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	9
Methocarbamol Tablets, USP 750 mg Rx Only	PD-Rx Pharmaceuticals, Inc.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	8
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	HAWAII REPACK, INC.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	2
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Preferred Pharmaceuticals Inc.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	6
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Bryant Ranch Prepack	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	103
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Bryant Ranch Prepack	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	103
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	St. Mary's Medical Park Pharmacy	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	4
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Bryant Ranch Prepack	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	105
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Oxford Pharmaceuticals, LLC	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	5
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	REMEDYREPACK INC.	2025-07-16	HUMAN PRESCRIPTION DRUG LABEL	9
Methocarbamol Tablets Rx Only	Advanced Rx of Tennessee, LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Bryant Ranch Prepack	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	106
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	5
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Redpharm Drug, Inc.	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Methocarbamol Tablets, USP 750 mg Rx Only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL	3
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-17	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	A-S Medication Solutions	2023-09-21	HUMAN PRESCRIPTION DRUG LABEL	7