Methocarbamol

Product NDC
25021-689
11-digit product format
250210689
Labeler code
25021
Product ID
25021-689_80ac4a92-7af8-4922-a48d-f42ac7391d1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA211504
Marketing category
ANDA
Marketing start
2025-10-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211504-001METHOCARBAMOLMETHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263f01610625f2…
2019-09-15 20:21 UTC2019-09A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211504-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211504-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211504-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211504-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211504-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211504-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211504-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211504-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211504-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211504-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211504-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211504-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211504-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211504-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211504-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211504-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211504-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211504-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211504-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211504-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211504-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A211504-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211504-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211504-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211504-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A211504-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211504-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211504-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211504-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211504-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211504-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211504-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211504-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211504-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211504-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211504-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211504-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211504-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211504-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211504-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
125OD7737XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238175Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
01e7e2c7-49eb-4afb-a496-f2bd901622e9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-689-10Methocarbamol25 in 1 CARTONINJECTION, SOLUTION251
25021-689-10Methocarbamol10 mL in 1 VIALINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-689-10ML - Milliliter25021-68937cdf4ae-edf3-46ed-9488-da35eca0046d12025-10-14

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLJVET PHARMACEUTICALS LLCd9e4748f-11c5-4d87-b260-1be94febe8062026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLSagent Pharmaceuticals01e7e2c7-49eb-4afb-a496-f2bd901622e92025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
ndc (product): 25021-689
MethocarbamolMETHOCARBAMOLGland Pharma Limited44c7fe99-8999-4747-9376-f13d3f9e56882020-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLMeitheal Pharmaceuticals Inc.b60000fc-e99b-4994-9d36-3907e0da9e062019-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLDr.Reddys Laboratories Inc.,c88898af-5cd8-7bed-a03e-2ab4488e20402018-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSN01e7e2c7-49eb-4afb-a496-f2bd901622e91
23817510 ML methocarbamol 100 MG/ML InjectionSCD01e7e2c7-49eb-4afb-a496-f2bd901622e91
238175methocarbamol 1000 MG per 10 ML InjectionSY01e7e2c7-49eb-4afb-a496-f2bd901622e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-689-102502106891025 VIAL in 1 CARTON (25021-689-10) / 10 mL in 1 VIAL25 vial2025-10-01NoNoCurrent