methocarbamol

Product NDC
36000-302
11-digit product format
360000302
Labeler code
36000
Product ID
36000-302_53ba7308-02bf-4520-ae39-5c69e17852c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA215065
Marketing category
ANDA
Marketing start
2022-07-14
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36000-302-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36000-302-25557ba5c1ecfa…9c80585c8c6e…

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
A215065-001METHOCARBAMOLMETHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2022-07-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2022-07-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2022-07-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2022-07-14e64feba35796…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215065-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IV2022-07-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-01-26 05:58 UTC2023-01A215065-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215065-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215065-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215065-001AP1e64feba35796…

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
a7f70b19-75ba-4e3d-b4fe-277fe7305bf0Available 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
36000-302-01methocarbamol10 mL in 1 VIALINJECTION105
36000-302-25methocarbamol25 in 1 CARTONINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-302METHOCARBAMOL INJECTION [BAXTER HEALTHCARE CORPORATION]4Current NDC, Legacy NDC, 2 package rows20241101_a7f70b19-75ba-4e3d-b4fe-277fe7305bf0.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
methocarbamolMETHOCARBAMOLBaxter Healthcare Corporationa7f70b19-75ba-4e3d-b4fe-277fe7305bf02020-09-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215065
application number: ANDA215065
ndc (product): 36000-302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNa7f70b19-75ba-4e3d-b4fe-277fe7305bf05
23817510 ML methocarbamol 100 MG/ML InjectionSCDa7f70b19-75ba-4e3d-b4fe-277fe7305bf05
238175methocarbamol 1000 MG per 10 ML InjectionSYa7f70b19-75ba-4e3d-b4fe-277fe7305bf05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36000-302-013600003020110 mL in 1 VIAL10 mlHistorical
36000-302-253600003022525 VIAL in 1 CARTON (36000-302-25) / 10 mL in 1 VIAL (36000-302-01) 25 vial2022-07-140000-00-00NoNoCurrent