FDA.reportPublic FDA data

Methocarbamol Tablets, USP, 750 mg

Product NDC
72789-521
11-digit product format
727890521
Labeler code
72789
Product ID
72789-521_4db4d9af-87e7-dce7-e063-6294a90acd01
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
2025-06-10
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol Tablets, USP, 750 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197944

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
72789-521-20Methocarbamol Tablets, USP, 750 mg20 in 1 BOTTLE, PLASTICTABLET, FILM COATED206
72789-521-30Methocarbamol Tablets, USP, 750 mg30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
72789-521-40Methocarbamol Tablets, USP, 750 mg40 in 1 BOTTLE, PLASTICTABLET, FILM COATED406
72789-521-60Methocarbamol Tablets, USP, 750 mg60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606
72789-521-82Methocarbamol Tablets, USP, 750 mg500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-521-20EA - Each72789-521cc0f1b30-5810-4f45-9592-52af5e7bedea12025-10-14
72789-521-30EA - Each72789-5210f7c9f62-afe0-48e7-8ebe-b4efe1ad01aa12025-12-16
72789-521-40EA - Each72789-52192528b1c-a67c-473b-b094-df7bb4432bc512026-04-20
72789-521-60EA - Each72789-5218249093a-36f0-4ade-9660-33cb53b7574b12025-10-14
72789-521-82EA - Each72789-52173958426-6968-4a3b-b206-d065e641156a12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c6
197944methocarbamol 750 MG Oral TabletSCD60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-521-207278905212020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-521-20) 2025-08-29NoNoHistorical
72789-521-307278905213030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-521-30) 2025-10-24NoNoHistorical
72789-521-407278905214040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-521-40) 2026-03-23NoNoHistorical
72789-521-607278905216060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-521-60) 2025-09-18NoNoHistorical
72789-521-8272789052182500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-521-82) 2025-08-15NoNoHistorical