FDA.reportPublic FDA data

Methocarbamol

Product NDC
43598-839
11-digit product format
435980839
Labeler code
43598
Product ID
43598-839_87da81ae-2159-f914-da9a-e6de28a93433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dr.Reddy�s Laboratories Inc.,
Application
ANDA211504
Marketing category
ANDA
Marketing start
2019-03-07
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
43598-839-11Methocarbamol10 mL in 1 VIALINJECTION102
43598-839-36Methocarbamol10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-839-11ML - Milliliter43598-83937168d03-5bb8-45db-9a7f-04457330dda512019-04-11
43598-839-36ML - Milliliter43598-839298952b3-0aba-4eda-b891-87ab66bc5c0d12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-839METHOCARBAMOL INJECTION [DR.REDDY’S LABORATORIES INC.,]2Current NDC, Legacy NDC, 2 package rows20190312_c88898af-5cd8-7bed-a03e-2ab4488e2040.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNc88898af-5cd8-7bed-a03e-2ab4488e20402
23817510 ML methocarbamol 100 MG/ML InjectionSCDc88898af-5cd8-7bed-a03e-2ab4488e20402
238175methocarbamol 1000 MG per 10 ML InjectionSYc88898af-5cd8-7bed-a03e-2ab4488e20402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-839-114359808391110 mL in 1 VIAL10 mlHistorical
43598-839-364359808393610 VIAL in 1 CARTON (43598-839-36) / 10 mL in 1 VIAL (43598-839-11) 10 vial2019-03-070000-00-00NoNoCurrent