FDA.reportPublic FDA data

Methocarbamol

Product NDC
80425-0171
11-digit product format
804250171
Labeler code
80425
Product ID
80425-0171_2a99b1dd-bed2-79f9-e063-6394a90a35f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
Substance
METHOCARBAMOL
Active strength
750 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
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
80425-0171-1Methocarbamol30 in 1 BOTTLETABLET, FILM COATED308
80425-0171-2Methocarbamol60 in 1 BOTTLETABLET, FILM COATED608
80425-0171-3Methocarbamol90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0171-1EA - Each80425-0171cdc53f27-e0d3-4ffb-8af5-d419758d22bc12023-06-06
80425-0171-2EA - Each80425-017104ca45d9-2d21-4e99-8b9a-247d01ab4b7b12023-06-06
80425-0171-3EA - Each80425-0171afb9cb2e-d86c-48b1-bb44-f5928747d6fe12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0171METHOCARBAMOL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_c9600cc9-7e27-6e19-e053-2995a90ab024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNc9600cc9-7e27-6e19-e053-2995a90ab0248
197944methocarbamol 750 MG Oral TabletSCDc9600cc9-7e27-6e19-e053-2995a90ab0248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0171-18042501710130 TABLET, FILM COATED in 1 BOTTLE (80425-0171-1) 2018-01-150000-00-00NoNoCurrent
80425-0171-28042501710260 TABLET, FILM COATED in 1 BOTTLE (80425-0171-2) 2018-01-150000-00-00NoNoCurrent
80425-0171-38042501710390 TABLET, FILM COATED in 1 BOTTLE (80425-0171-3) 2018-01-150000-00-00NoNoCurrent