FDA.reportPublic FDA data

Methocarbamol

Product NDC
72789-428
11-digit product format
727890428
Labeler code
72789
Product ID
72789-428_4123c4a2-42dd-322b-e063-6294a90a2981
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
72789-428-18Methocarbamol18 in 1 BOTTLE, PLASTICTABLET187
72789-428-30Methocarbamol30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-428-18EA - Each72789-4289bb115f8-e8c3-4a65-bf3b-67d4584e5d8512025-01-14
72789-428-30EA - Each72789-4284b758f41-6f4a-4347-a06d-23a2e919545212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-428METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20241122_6b9ed3a4-46d5-462e-ac93-6b959b314d77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN6b9ed3a4-46d5-462e-ac93-6b959b314d777
197943methocarbamol 500 MG Oral TabletSCD6b9ed3a4-46d5-462e-ac93-6b959b314d777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-428-187278904281818 TABLET in 1 BOTTLE, PLASTIC (72789-428-18) 18 tablet2024-11-20NoNoCurrent
72789-428-307278904283030 TABLET in 1 BOTTLE, PLASTIC (72789-428-30) 30 tablet2024-09-12NoNoCurrent