Methocarbamol

Product NDC: 72162-1363
Requested package NDC: 72162-1363-1
11-digit product format: 721621363
Labeler code: 72162
Product ID: 72162-1363_51c6c6b0-3cfb-445a-bde4-0fedf48c18b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA086989
Marketing category: ANDA
Marketing start: 2017-12-15
Substance: METHOCARBAMOL
Active strength: 500 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.

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	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086989-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086989-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086989-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086989-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086989-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086989-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086989-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086989-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086989-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086989-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086989-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086989-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086989-001	AA	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A086989-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086989-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086989-001	AA	1	`cb3db0bc1861…`

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	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
8cf27774-82ed-4ed1-a55d-41bf476745db	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	Strength	SPL version
72162-1363-1	Methocarbamol	100 in 1 BOTTLE	TABLET	100		100
72162-1363-5	Methocarbamol	500 in 1 BOTTLE	TABLET	500		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1363-1	EA - Each	72162-1363	29787d5b-f8ca-4099-8f79-c05cdb2367c6	1	2024-04-05
72162-1363-5	EA - Each	72162-1363	392ad53b-f787-4153-95eb-a504edfca191	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1363	METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 2 package rows	20240206_8cf27774-82ed-4ed1-a55d-41bf476745db.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	43ea5baa-4200-47ff-8819-44c802cba977	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	8cf27774-82ed-4ed1-a55d-41bf476745db	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989 ndc (package): 72162-1363-1 ndc (product): 72162-1363 ndc11 (package): 72162136301
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	f1bce76f-4c3a-40d2-8107-afc0d3a6ba19	2023-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	27c39343-44e0-4ca6-a67f-1e6d11dd6799	2021-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	75b964b7-3e76-4460-9777-7656b5daa32e	2020-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086989 application number: ANDA086989

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	8cf27774-82ed-4ed1-a55d-41bf476745db	100
197943	methocarbamol 500 MG Oral Tablet	SCD	8cf27774-82ed-4ed1-a55d-41bf476745db	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1363-1	72162136301	100 TABLET in 1 BOTTLE (72162-1363-1)	100 tablet	2024-02-05	No	No	Current