Methocarbamol

Product NDC: 68083-317
11-digit product format: 680830317
Labeler code: 68083
Product ID: 68083-317_36c2242f-82d7-4faa-a640-0a6e269038ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA211504
Marketing category: ANDA
Marketing start: 2018-11-01
Substance: METHOCARBAMOL
Active strength: 100 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211504-001	METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP		2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211504-001	AP

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211504-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211504-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211504-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211504-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211504-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211504-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211504-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211504-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211504-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211504-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211504-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211504-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211504-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211504-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211504-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211504-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211504-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211504-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211504-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211504-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211504-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211504-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211504-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211504-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211504-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211504-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211504-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211504-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211504-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211504-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211504-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211504-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211504-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211504-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211504-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211504-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211504-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211504-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211504-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211504-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methocarbamol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOCARBAMOL	100 mg/mL

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
238175	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
44c7fe99-8999-4747-9376-f13d3f9e5688	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
68083-317-01	Methocarbamol	10 mL in 1 VIAL	INJECTION	10		7
68083-317-25	Methocarbamol	25 in 1 CARTON	INJECTION	25		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-317	METHOCARBAMOL INJECTION [GLAND PHARMA LIMITED]	7	Current NDC, Legacy NDC, 2 package rows	20200723_44c7fe99-8999-4747-9376-f13d3f9e5688.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	JVET PHARMACEUTICALS LLC	d9e4748f-11c5-4d87-b260-1be94febe806	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504
Methocarbamol	METHOCARBAMOL	Sagent Pharmaceuticals	01e7e2c7-49eb-4afb-a496-f2bd901622e9	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504
Methocarbamol	METHOCARBAMOL	Gland Pharma Limited	44c7fe99-8999-4747-9376-f13d3f9e5688	2020-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504 ndc (product): 68083-317
Methocarbamol	METHOCARBAMOL	Meitheal Pharmaceuticals Inc.	b60000fc-e99b-4994-9d36-3907e0da9e06	2019-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504
Methocarbamol	METHOCARBAMOL	Dr.Reddys Laboratories Inc.,	c88898af-5cd8-7bed-a03e-2ab4488e2040	2018-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504

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
238175	methocarbamol 1000 MG in 10 ML Injection	PSN	44c7fe99-8999-4747-9376-f13d3f9e5688	7
238175	10 ML methocarbamol 100 MG/ML Injection	SCD	44c7fe99-8999-4747-9376-f13d3f9e5688	7
238175	methocarbamol 1000 MG per 10 ML Injection	SY	44c7fe99-8999-4747-9376-f13d3f9e5688	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-317-01	68083031701	10 mL in 1 VIAL	10 ml					Historical
68083-317-25	68083031725	25 VIAL in 1 CARTON (68083-317-25) / 10 mL in 1 VIAL (68083-317-01)	25 vial	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Injection, USP (For Intravenous or Intramuscular Injection) Rx only	Gland Pharma Limited	2020-07-18	Human Prescription Drug Label	7