FDA.reportPublic FDA data

Methocarbamol

Product NDC
80425-0579
11-digit product format
804250579
Labeler code
80425
Product ID
80425-0579_4de110ad-5ce3-6cf6-e063-6394a90abb75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA209312
Marketing category
ANDA
Marketing start
2025-03-25
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
80425-0579-1Methocarbamol30 in 1 BOTTLETABLET, COATED301
80425-0579-2Methocarbamol60 in 1 BOTTLETABLET, COATED601
80425-0579-3Methocarbamol90 in 1 BOTTLETABLET, COATED901
80425-0579-4Methocarbamol120 in 1 BOTTLETABLET, COATED1201
80425-0579-5Methocarbamol180 in 1 BOTTLETABLET, COATED1801
80425-0579-6Methocarbamol12 in 1 BOTTLETABLET, COATED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0579-1EA - Each80425-0579cf25787e-8225-4d2b-a159-edee656d08f612026-04-20
80425-0579-2EA - Each80425-057900f9291b-42b5-48b2-a8df-7401985d4b0d12026-04-20
80425-0579-3EA - Each80425-0579981b0b77-cfa0-4a40-af26-cb7260df0b3812026-04-20
80425-0579-4EA - Each80425-05798c983aec-93c9-408d-a26c-03cbbeac50ca12026-04-20
80425-0579-5EA - Each80425-0579f893276d-53ce-42e9-933a-89d75187ea5a12026-04-20
80425-0579-6EA - Each80425-057996f3e66a-7ec6-493f-84da-68b8f77c8d8d12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN4de118fe-bd8e-6cc4-e063-6394a90a13201
197943methocarbamol 500 MG Oral TabletSCD4de118fe-bd8e-6cc4-e063-6394a90a13201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0579-18042505790130 TABLET, COATED in 1 BOTTLE (80425-0579-1) 2025-03-25NoNoHistorical
80425-0579-28042505790260 TABLET, COATED in 1 BOTTLE (80425-0579-2) 2025-03-25NoNoHistorical
80425-0579-38042505790390 TABLET, COATED in 1 BOTTLE (80425-0579-3) 2025-03-25NoNoHistorical
80425-0579-480425057904120 TABLET, COATED in 1 BOTTLE (80425-0579-4) 2025-03-25NoNoHistorical
80425-0579-580425057905180 TABLET, COATED in 1 BOTTLE (80425-0579-5) 2025-03-25NoNoHistorical
80425-0579-68042505790612 TABLET, COATED in 1 BOTTLE (80425-0579-6) 2025-03-25NoNoHistorical