FDA.reportPublic FDA data

Methocarbamol

Product NDC
72789-397
11-digit product format
727890397
Labeler code
72789
Product ID
72789-397_4123336c-9e82-3a81-e063-6394a90aed54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040489
Marketing category
ANDA
Marketing start
2019-08-15
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

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
72789-397-01Methocarbamol100 in 1 BOTTLE, PLASTICTABLET1008
72789-397-82Methocarbamol500 in 1 BOTTLE, PLASTICTABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-397-01EA - Each72789-397936401b2-5d39-41e9-becb-5ddd36b0589312024-06-10
72789-397-82EA - Each72789-397f5b237d1-b104-4aee-ae98-147bdce1aaaf12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-397METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.]7Current NDC, 2 package rows20241115_0deb5368-ffdc-40fc-a97c-ba89b7a97e50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN0deb5368-ffdc-40fc-a97c-ba89b7a97e508
197943methocarbamol 500 MG Oral TabletSCD0deb5368-ffdc-40fc-a97c-ba89b7a97e508

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-397-0172789039701100 TABLET in 1 BOTTLE, PLASTIC (72789-397-01) 100 tablet2024-05-07NoNoCurrent
72789-397-8272789039782500 TABLET in 1 BOTTLE, PLASTIC (72789-397-82) 500 tablet2024-05-07NoNoCurrent