Methocarbamol

Product NDC: 68788-7980
11-digit product format: 687887980
Labeler code: 68788
Product ID: 68788-7980_548ebcd2-1b13-46a2-adc8-da5e40edd0c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
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: 2026-12-31
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
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 ndc (product): 68788-7980
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4ef1c2c0-31e1-4f85-b645-ff47a057a994	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
68788-7980-3	Methocarbamol	30 in 1 BOTTLE	TABLET	30	5
68788-7980-6	Methocarbamol	60 in 1 BOTTLE	TABLET	60	5
68788-7980-9	Methocarbamol	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7980-3	EA - Each	68788-7980	0951c50a-60de-466f-8539-729c9963e29f	1	2021-08-05
68788-7980-6	EA - Each	68788-7980	bc76bcc9-51f2-45fe-85c4-c230a16108b6	1	2021-08-05
68788-7980-9	EA - Each	68788-7980	838bb438-1398-4f64-a23c-1b9144e459cb	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7980	METHOCARBAMOL TABLET [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 3 package rows	20240716_4ef1c2c0-31e1-4f85-b645-ff47a057a994.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	4ef1c2c0-31e1-4f85-b645-ff47a057a994	5
197944	methocarbamol 750 MG Oral Tablet	SCD	4ef1c2c0-31e1-4f85-b645-ff47a057a994	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7980-3	68788798003	30 TABLET in 1 BOTTLE (68788-7980-3)	30 tablet	2019-08-15	0000-00-00	No	No	Current
68788-7980-6	68788798006	60 TABLET in 1 BOTTLE (68788-7980-6)	60 tablet	2019-08-15	0000-00-00	No	No	Current
68788-7980-9	68788798009	90 TABLET in 1 BOTTLE (68788-7980-9)	90 tablet	2019-08-15	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	Preferred Pharmaceuticals Inc.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	6