FDA.reportPublic FDA data

Methocarbamol

Product NDC
80425-0578
11-digit product format
804250578
Labeler code
80425
Product ID
80425-0578_4cefe49f-cada-a26f-e063-6394a90ac478
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
2026-03-13
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
80425-0578-1Methocarbamol30 in 1 BOTTLETABLET, COATED301
80425-0578-2Methocarbamol60 in 1 BOTTLETABLET, COATED601
80425-0578-3Methocarbamol90 in 1 BOTTLETABLET, COATED901
80425-0578-4Methocarbamol120 in 1 BOTTLETABLET, COATED1201
80425-0578-5Methocarbamol180 in 1 BOTTLETABLET, COATED1801
80425-0578-6Methocarbamol12 in 1 BOTTLETABLET, COATED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0578-1EA - Each80425-0578da3567d4-bb83-44fb-905f-4a651d71c27012026-04-20
80425-0578-2EA - Each80425-0578033414f4-85a3-4583-a50d-8251be9e826312026-04-20
80425-0578-3EA - Each80425-05780353afdf-b9ec-4d19-bd1a-6096749ffb3612026-04-20
80425-0578-4EA - Each80425-05789a4a59e4-e824-4936-836d-cdc243c8ba3a12026-04-20
80425-0578-5EA - Each80425-057899689636-1118-4305-aa64-907b44e7c31f12026-04-20
80425-0578-6EA - Each80425-05784c3a5bfa-04e7-47ac-b2df-c7d968e62a5c12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN4cefe51c-d824-a862-e063-6394a90a77171
197943methocarbamol 500 MG Oral TabletSCD4cefe51c-d824-a862-e063-6394a90a77171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0578-18042505780130 TABLET, COATED in 1 BOTTLE (80425-0578-1) 2026-03-13NoNoHistorical
80425-0578-28042505780260 TABLET, COATED in 1 BOTTLE (80425-0578-2) 2026-03-13NoNoHistorical
80425-0578-38042505780390 TABLET, COATED in 1 BOTTLE (80425-0578-3) 2026-03-13NoNoHistorical
80425-0578-480425057804120 TABLET, COATED in 1 BOTTLE (80425-0578-4) 2026-03-13NoNoHistorical
80425-0578-580425057805180 TABLET, COATED in 1 BOTTLE (80425-0578-5) 2026-03-13NoNoHistorical
80425-0578-68042505780612 TABLET, COATED in 1 BOTTLE (80425-0578-6) 2026-03-13NoNoHistorical