FDA.reportPublic FDA data

Methocarbamol Tablets, USP, 500 mg

Product NDC
72789-499
11-digit product format
727890499
Labeler code
72789
Product ID
72789-499_396bde13-ddeb-7ed6-e063-6294a90abdd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA212623
Marketing category
ANDA
Marketing start
2024-01-01
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 Tablets, USP, 500 mg
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
72789-499-18Methocarbamol Tablets, USP, 500 mg18 in 1 BOTTLE, PLASTICTABLET, FILM COATED184
72789-499-20Methocarbamol Tablets, USP, 500 mg20 in 1 BOTTLE, PLASTICTABLET, FILM COATED204
72789-499-28Methocarbamol Tablets, USP, 500 mg28 in 1 BOTTLE, PLASTICTABLET, FILM COATED284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-499-18EA - Each72789-4991d600402-338f-4168-8e69-7654397e250012025-06-13
72789-499-20EA - Each72789-4995008ab11-2368-4780-bd0a-01f48b1a9a3712025-06-13
72789-499-28EA - Each72789-499ae9db331-7874-40f7-ae75-a2ec691eb08212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-499METHOCARBAMOL TABLETS, USP, 500 MG (METHOCARBAMOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3Current NDC, 3 package rows20250429_6500c6eb-fa1e-46a5-839f-13047e107e97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN6500c6eb-fa1e-46a5-839f-13047e107e974
197943methocarbamol 500 MG Oral TabletSCD6500c6eb-fa1e-46a5-839f-13047e107e974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-499-187278904991818 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-499-18) 2025-04-16NoNoCurrent
72789-499-207278904992020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-499-20) 2025-04-28NoNoCurrent
72789-499-287278904992828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-499-28) 2025-07-08NoNoCurrent