Methocarbamol

Product NDC: 80425-0171
11-digit product format: 804250171
Labeler code: 80425
Product ID: 80425-0171_2a99b1dd-bed2-79f9-e063-6394a90a35f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA208507
Marketing category: ANDA
Marketing start: 2018-01-15
Substance: METHOCARBAMOL
Active strength: 750 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A208507-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2017-07-21
A208507-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208507-001	AA
A208507-002	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	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`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	A208507-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208507-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208507-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208507-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208507-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208507-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208507-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208507-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208507-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208507-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208507-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208507-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208507-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208507-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208507-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208507-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208507-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208507-002	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: 2026-12-31

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
c9600cc9-7e27-6e19-e053-2995a90ab024	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
80425-0171-1	Methocarbamol	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
80425-0171-2	Methocarbamol	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
80425-0171-3	Methocarbamol	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0171-1	EA - Each	80425-0171	cdc53f27-e0d3-4ffb-8af5-d419758d22bc	1	2023-06-06
80425-0171-2	EA - Each	80425-0171	04ca45d9-2d21-4e99-8b9a-247d01ab4b7b	1	2023-06-06
80425-0171-3	EA - Each	80425-0171	afb9cb2e-d86c-48b1-bb44-f5928747d6fe	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0171	METHOCARBAMOL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	8	Current NDC, Legacy NDC, 3 package rows	20250101_c9600cc9-7e27-6e19-e053-2995a90ab024.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	3212f121-9428-4186-8f00-accf08bca473	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	288a3bcd-a2c8-4a9b-9602-59c0493b4a8d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3b0e60a7-3cff-4665-a473-ad3257619cdd	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	943fe701-5d7d-4abe-a529-c5a548e94bc6	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	440bf1ba-a704-4c35-bece-0a0987fc0c11	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	12c8da39-3a0e-4303-9655-29dd83507837	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	UNICHEM PHARMACEUTICALS (USA), INC.	5777cbb0-b5fd-4b36-ac1d-bc105fe96888	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	ff572473-90e3-4f3b-a40e-8b97b86d327b	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9357672f-5d4d-40f5-a304-e0c34e174dc3	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	c06c4a63-491c-baa2-e053-2a95a90a09ff	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	c9600cc9-7e27-6e19-e053-2995a90ab024	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 80425-0171
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	c40d5c1d-9bd8-44aa-85a4-e1a34e1d3673	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	201205d1-22f2-46bb-b298-02d4978ba568	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	39b4362e-a26e-49cb-9d06-898bc9b0e005	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	d825e4d6-8b00-473a-a6e6-90f5c3ad5bec	2018-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507

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	c9600cc9-7e27-6e19-e053-2995a90ab024	8
197944	methocarbamol 750 MG Oral Tablet	SCD	c9600cc9-7e27-6e19-e053-2995a90ab024	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0171-1	80425017101	30 TABLET, FILM COATED in 1 BOTTLE (80425-0171-1)	2018-01-15	0000-00-00	No	No	Current
80425-0171-2	80425017102	60 TABLET, FILM COATED in 1 BOTTLE (80425-0171-2)	2018-01-15	0000-00-00	No	No	Current
80425-0171-3	80425017103	90 TABLET, FILM COATED in 1 BOTTLE (80425-0171-3)	2018-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	8