FDA.reportPublic FDA data

Methocarbamol

Product NDC
68788-8867
11-digit product format
687888867
Labeler code
68788
Product ID
68788-8867_38d8b457-0c0f-45cb-bf90-965c5a01b198
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
2025-04-23
Substance
METHOCARBAMOL
Active strength
500 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
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
68788-8867-3Methocarbamol30 in 1 BOTTLETABLET, FILM COATED301
68788-8867-6Methocarbamol60 in 1 BOTTLETABLET, FILM COATED601
68788-8867-9Methocarbamol90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8867-3EA - Each68788-88671f12a43b-6bb2-45dd-b653-fce6f56be82612025-07-08
68788-8867-6EA - Each68788-8867f03e2e4b-87cd-4838-90bc-469a0a46067a12025-07-08
68788-8867-9EA - Each68788-8867c85629bd-0536-4fe8-b207-467c6ec542c612025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8867METHOCARBAMOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250427_38d8b457-0c0f-45cb-bf90-965c5a01b198.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN38d8b457-0c0f-45cb-bf90-965c5a01b1981
197943methocarbamol 500 MG Oral TabletSCD38d8b457-0c0f-45cb-bf90-965c5a01b1981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8867-36878888670330 TABLET, FILM COATED in 1 BOTTLE (68788-8867-3) 2025-04-23NoNoHistorical
68788-8867-66878888670660 TABLET, FILM COATED in 1 BOTTLE (68788-8867-6) 2025-04-23NoNoHistorical
68788-8867-96878888670990 TABLET, FILM COATED in 1 BOTTLE (68788-8867-9) 2025-04-23NoNoHistorical