Methocarbamol

Product NDC: 71205-167
11-digit product format: 712050167
Labeler code: 71205
Product ID: 71205-167_3f2b80a9-5d79-4c3f-86f6-85621b565835
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol Tablets
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA209312
Marketing category: ANDA
Marketing start: 2018-07-02
Substance: METHOCARBAMOL
Active strength: 500 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
A209312-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07
A209312-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209312-001	AA
A209312-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2018-05-07	`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	A209312-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209312-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209312-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209312-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209312-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209312-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209312-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209312-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209312-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209312-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209312-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209312-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209312-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209312-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209312-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209312-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209312-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209312-002	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	500 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
197943	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
23163bc1-dec7-41f6-baed-eedebfd6be7e	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
71205-167-06	Methocarbamol	6 in 1 BOTTLE	TABLET, COATED	6	4
71205-167-09	Methocarbamol	9 in 1 BOTTLE	TABLET, COATED	9	4
71205-167-30	Methocarbamol	30 in 1 BOTTLE	TABLET, COATED	30	4
71205-167-60	Methocarbamol	60 in 1 BOTTLE	TABLET, COATED	60	4
71205-167-90	Methocarbamol	90 in 1 BOTTLE	TABLET, COATED	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-167-30	EA - Each	71205-167	9333d216-7d25-4ec9-9bd1-431851bbb1a7	1	2019-02-13
71205-167-60	EA - Each	71205-167	212191c0-91ce-4ed6-bc9d-87fb3490c063	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-167	METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 5 package rows	20220426_23163bc1-dec7-41f6-baed-eedebfd6be7e.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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL TABLETS	Northwind Health Company, LLC	f2b4ed5f-3489-9ee4-e053-2995a90a25f0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Redpharm Drug	46e983de-434e-7ff3-e063-6394a90aa466	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Granules India Ltd	42c0a177-7d62-4bcf-9fce-7dd484cda4d5	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	PHOENIX RX LLC	414b2fe0-fa2b-2b18-e063-6394a90ab2b9	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	f07c0a35-fb5d-43a1-a33e-d6a51a5fcd77	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	5f746f0f-e884-46d9-a104-529293b0fb90	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	fe872a3a-fb14-4a0a-b9e4-c9f1885b4978	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	2a99a422-6bad-4316-90bc-e7c2d1e3fb53	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Asclemed USA, Inc.	edbcf8c6-0df8-4e72-885b-16d378f06c7b	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	af73ae4b-bcf5-2e21-e053-2a95a90a2dce	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Pharmasource Meds, LLC	f43a9389-c641-ce49-e053-2a95a90a537f	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Proficient Rx LP	f6193255-0e83-4510-bc86-30c926ee8fd1	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Aphena Pharma Solutions - Tennessee, LLC	3757cd8e-6054-4b75-bb04-d11f34c65cbe	2018-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312

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	23163bc1-dec7-41f6-baed-eedebfd6be7e	4
197943	methocarbamol 500 MG Oral Tablet	SCD	23163bc1-dec7-41f6-baed-eedebfd6be7e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-167-06	71205016706	6 TABLET, COATED in 1 BOTTLE (71205-167-06)	2026-05-13		No	No	Current
71205-167-09	71205016709	9 TABLET, COATED in 1 BOTTLE (71205-167-09)	2026-05-13		No	No	Current
71205-167-30	71205016730	30 TABLET, COATED in 1 BOTTLE (71205-167-30)	2018-12-01	0000-00-00	No	No	Current
71205-167-60	71205016760	60 TABLET, COATED in 1 BOTTLE (71205-167-60)	2018-12-01	0000-00-00	No	No	Current
71205-167-90	71205016790	90 TABLET, COATED in 1 BOTTLE (71205-167-90)	2018-12-01	0000-00-00	No	No	Current