FDA.reportPublic FDA data

Methocarbamol

Product NDC
71288-716
11-digit product format
712880716
Labeler code
71288
Product ID
71288-716_9e2c879f-7485-4071-ad3b-c773985048fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211504
Marketing category
ANDA
Marketing start
2018-12-17
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
71288-716-10Methocarbamol25 in 1 CARTONINJECTION, SOLUTION253
71288-716-11Methocarbamol10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-716-10ML - Milliliter71288-716b3139ea0-d0c4-470e-b512-c6096c93d64a12019-01-24
71288-716-11ML - Milliliter71288-716f7a3cc4a-189e-4aae-afe7-4319c4fb89c312021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-716METHOCARBAMOL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20210324_b60000fc-e99b-4994-9d36-3907e0da9e06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNb60000fc-e99b-4994-9d36-3907e0da9e063
23817510 ML methocarbamol 100 MG/ML InjectionSCDb60000fc-e99b-4994-9d36-3907e0da9e063
238175methocarbamol 1000 MG per 10 ML InjectionSYb60000fc-e99b-4994-9d36-3907e0da9e063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-716-107128807161025 VIAL, SINGLE-DOSE in 1 CARTON (71288-716-10) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-716-11) 2018-12-170000-00-00NoNoCurrent
71288-716-117128807161110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical