FDA.reportPublic FDA data

Methocarbamol

Product NDC
80425-0577
11-digit product format
804250577
Labeler code
80425
Product ID
80425-0577_4b1d76e9-2df1-0009-e063-6394a90a2c09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA040489
Marketing category
ANDA
Marketing start
2026-02-18
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
80425-0577-1Methocarbamol30 in 1 BOTTLETABLET301
80425-0577-2Methocarbamol60 in 1 BOTTLETABLET601
80425-0577-3Methocarbamol90 in 1 BOTTLETABLET901
80425-0577-4Methocarbamol120 in 1 BOTTLETABLET1201
80425-0577-5Methocarbamol180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0577-1EA - Each80425-0577e69988fb-481c-4591-8c2c-e70e3ae4626312026-03-17
80425-0577-2EA - Each80425-0577eb16c213-0218-44d1-9ad8-e072c005bfd112026-03-17
80425-0577-3EA - Each80425-0577307f4d0c-753e-495a-a995-83330851a73512026-03-17
80425-0577-4EA - Each80425-057718269cef-daf0-46df-8fc6-19b620927eb912026-03-17
80425-0577-5EA - Each80425-05771899fca7-eb44-4026-af6a-8f818ebfaa7012026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN4b1d8ac6-d25d-1c37-e063-6394a90aba291
197943methocarbamol 500 MG Oral TabletSCD4b1d8ac6-d25d-1c37-e063-6394a90aba291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0577-18042505770130 TABLET in 1 BOTTLE (80425-0577-1) 30 tablet2026-02-18NoNoHistorical
80425-0577-28042505770260 TABLET in 1 BOTTLE (80425-0577-2) 60 tablet2026-02-18NoNoHistorical
80425-0577-38042505770390 TABLET in 1 BOTTLE (80425-0577-3) 90 tablet2026-02-18NoNoHistorical
80425-0577-480425057704120 TABLET in 1 BOTTLE (80425-0577-4) 120 tablet2026-02-18NoNoHistorical
80425-0577-580425057705180 TABLET in 1 BOTTLE (80425-0577-5) 180 tablet2026-02-18NoNoHistorical