Methocarbamol

Product NDC
63323-778
11-digit product format
633230778
Labeler code
63323
Product ID
63323-778_ee1af98a-62a0-4831-b3c1-45607737b32f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA209331
Marketing category
ANDA
Marketing start
2018-04-17
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

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 Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui238175

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
63323-778-10Methocarbamol25 in 1 CARTONINJECTION, SOLUTION255
63323-778-21Methocarbamol10 mL in 1 VIALINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-778-10ML - Milliliter63323-778b3978f25-a8cb-4792-aeff-8d42e1d1b68512019-01-24
63323-778-21ML - Milliliter63323-778ab52a6b1-e5e7-4da1-aff6-66e70b6ec7a412019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-778METHOCARBAMOL (METHOCARBAMOL) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20240913_bdf17640-221c-4c80-b48c-101daaece1d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNbdf17640-221c-4c80-b48c-101daaece1d65
23817510 ML methocarbamol 100 MG/ML InjectionSCDbdf17640-221c-4c80-b48c-101daaece1d65
238175methocarbamol 1000 MG per 10 ML InjectionSYbdf17640-221c-4c80-b48c-101daaece1d65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-778-106332307781025 VIAL in 1 CARTON (63323-778-10) / 10 mL in 1 VIAL (63323-778-21) 25 vial2018-04-170000-00-00NoNoCurrent
63323-778-216332307782110 mL in 1 VIAL10 mlHistorical