FDA.reportPublic FDA data

Methocarbamol

Product NDC
68788-8876
11-digit product format
687888876
Labeler code
68788
Product ID
68788-8876_9169399e-bca1-4c44-9a93-886f3650e44d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213967
Marketing category
ANDA
Marketing start
2025-05-19
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
68788-8876-3Methocarbamol30 in 1 BOTTLETABLET, FILM COATED301
68788-8876-6Methocarbamol60 in 1 BOTTLETABLET, FILM COATED601
68788-8876-9Methocarbamol90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8876-3EA - Each68788-88762e6bdb72-e7bd-4179-9ee6-1df212cdbccb12025-07-08
68788-8876-6EA - Each68788-8876170045bb-24ca-42eb-8d4f-30eb03e3f0f012025-07-08
68788-8876-9EA - Each68788-887642c4f6ff-417f-49cb-bd36-45eb9943215412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8876METHOCARBAMOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250521_9169399e-bca1-4c44-9a93-886f3650e44d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN9169399e-bca1-4c44-9a93-886f3650e44d1
197944methocarbamol 750 MG Oral TabletSCD9169399e-bca1-4c44-9a93-886f3650e44d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8876-36878888760330 TABLET, FILM COATED in 1 BOTTLE (68788-8876-3) 2025-05-19NoNoHistorical
68788-8876-66878888760660 TABLET, FILM COATED in 1 BOTTLE (68788-8876-6) 2025-05-19NoNoHistorical
68788-8876-96878888760990 TABLET, FILM COATED in 1 BOTTLE (68788-8876-9) 2025-05-19NoNoHistorical