Methocarbamol

Product NDC
25021-675
11-digit product format
250210675
Labeler code
25021
Product ID
25021-675_5b7bad7e-ec8a-4e45-8379-b1229a679030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA205404
Marketing category
ANDA
Marketing start
2018-02-15
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
A205404-001METHOCARBAMOLMETHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205404-001AP

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 UTC2026-02A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205404-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-18cb3db0bc1861…

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 UTC2026-02A205404-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205404-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205404-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205404-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205404-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205404-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205404-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205404-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205404-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205404-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205404-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205404-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205404-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205404-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205404-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205404-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205404-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205404-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205404-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205404-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205404-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A205404-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205404-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205404-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205404-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A205404-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205404-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205404-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205404-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205404-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205404-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205404-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205404-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205404-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205404-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205404-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205404-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205404-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205404-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205404-001AP1cb3db0bc1861…

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
bc925726-4949-4647-bce8-e1180d36abe4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-675-10Methocarbamol10 mL in 1 VIALINJECTION, SOLUTION105
25021-675-10Methocarbamol25 in 1 CARTONINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-675-10ML - Milliliter25021-675a4fbaa39-b11b-4113-a06d-faa5e6491fd912018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-675METHOCARBAMOL INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20230810_bc925726-4949-4647-bce8-e1180d36abe4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLSagent Pharmaceuticalsbc925726-4949-4647-bce8-e1180d36abe42021-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205404
application number: ANDA205404
ndc (product): 25021-675

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNbc925726-4949-4647-bce8-e1180d36abe45
23817510 ML methocarbamol 100 MG/ML InjectionSCDbc925726-4949-4647-bce8-e1180d36abe45
238175methocarbamol 1000 MG per 10 ML InjectionSYbc925726-4949-4647-bce8-e1180d36abe45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-675-102502106751025 VIAL in 1 CARTON (25021-675-10) / 10 mL in 1 VIAL25 vial2018-02-150000-00-00NoNoCurrent