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

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
68083-317-01Methocarbamol10 mL in 1 VIALINJECTION107
68083-317-25Methocarbamol25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-317METHOCARBAMOL INJECTION [GLAND PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20200723_44c7fe99-8999-4747-9376-f13d3f9e5688.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSN44c7fe99-8999-4747-9376-f13d3f9e56887
23817510 ML methocarbamol 100 MG/ML InjectionSCD44c7fe99-8999-4747-9376-f13d3f9e56887
238175methocarbamol 1000 MG per 10 ML InjectionSY44c7fe99-8999-4747-9376-f13d3f9e56887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-317-016808303170110 mL in 1 VIAL10 mlHistorical
68083-317-256808303172525 VIAL in 1 CARTON (68083-317-25) / 10 mL in 1 VIAL (68083-317-01) 25 vial2018-11-010000-00-00NoNoCurrent