FDA.reportPublic FDA data

Methocarbamol

Product NDC
72789-012
11-digit product format
727890012
Labeler code
72789
Product ID
72789-012_4af2fbb0-4343-0414-e063-6294a90aa54c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2027-12-31

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
72789-012-18Methocarbamol18 in 1 BOTTLE, PLASTICTABLET, FILM COATED1815
72789-012-20Methocarbamol20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2015
72789-012-24Methocarbamol24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2415
72789-012-30Methocarbamol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015
72789-012-40Methocarbamol40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-012-18EA - Each72789-012c7aa8ae6-d3c6-45e9-8c90-f3a42c653dbc12020-02-13
72789-012-20EA - Each72789-0123bff34fa-ca67-45ce-b95e-3bf153bb6d3e12019-10-07
72789-012-24EA - Each72789-012aa7ecadb-e9ea-475e-9de1-d67723727ee712021-06-02
72789-012-30EA - Each72789-01208c43854-2569-4884-b7ad-7df34030e42e12021-11-09
72789-012-40EA - Each72789-012d74a9da2-44bf-4aae-9e77-977f62a8a33d12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-012METHOCARBAMOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 5 package rows20240719_288a3bcd-a2c8-4a9b-9602-59c0493b4a8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN288a3bcd-a2c8-4a9b-9602-59c0493b4a8d15
197943methocarbamol 500 MG Oral TabletSCD288a3bcd-a2c8-4a9b-9602-59c0493b4a8d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-012-187278900121818 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-18) 2019-12-190000-00-00NoNoCurrent
72789-012-207278900122020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-20) 2019-09-200000-00-00NoNoCurrent
72789-012-247278900122424 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-24) 2021-05-050000-00-00NoNoCurrent
72789-012-307278900123030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-30) 2021-08-100000-00-00NoNoCurrent
72789-012-407278900124040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-40) 2020-06-160000-00-00NoNoCurrent