FDA.reportPublic FDA data

Methocarbamol

Product NDC
72865-233
11-digit product format
728650233
Labeler code
72865
Product ID
72865-233_10a187fd-d89c-8820-e063-6394a90a510e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA090200
Marketing category
ANDA
Marketing start
2024-02-02
Substance
METHOCARBAMOL
Active strength
500 mg/1
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
METHOCARBAMOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943, 197944

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
72865-233-01Methocarbamol100 in 1 BOTTLETABLET1001
72865-233-05Methocarbamol500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-233-01EA - Each72865-2336e3eb3cd-6b87-472b-9033-afbf193f526612024-06-10
72865-233-05EA - Each72865-2334074c1be-c7db-4674-a18e-ce6f0e65bb4e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-233METHOCARBAMOL (METHOCARBAMOL) TABLET [XLCARE PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240206_f8bfb5cb-b7d0-4e09-b6bd-97a51d82c991.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN1880efb2-b97e-1e4d-e063-6294a90ab3e32
197943methocarbamol 500 MG Oral TabletSCD1880efb2-b97e-1e4d-e063-6294a90ab3e32
197943methocarbamol 500 MG Oral TabletPSNf8bfb5cb-b7d0-4e09-b6bd-97a51d82c9911
197944methocarbamol 750 MG Oral TabletPSNf8bfb5cb-b7d0-4e09-b6bd-97a51d82c9911
197943methocarbamol 500 MG Oral TabletSCDf8bfb5cb-b7d0-4e09-b6bd-97a51d82c9911
197944methocarbamol 750 MG Oral TabletSCDf8bfb5cb-b7d0-4e09-b6bd-97a51d82c9911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-233-0172865023301100 TABLET in 1 BOTTLE (72865-233-01) 100 tablet2024-02-02NoNoCurrent
72865-233-0572865023305500 TABLET in 1 BOTTLE (72865-233-05) 500 tablet2024-02-02NoNoCurrent