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

openFDA Listing Details

Product ID
68788-8867_38d8b457-0c0f-45cb-bf90-965c5a01b198
SPL ID
38d8b457-0c0f-45cb-bf90-965c5a01b198
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Methocarbamol
Generic name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Marketing start
2025-04-23
Marketing category
ANDA
Application number
ANDA213967
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
METHOCARBAMOL500 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii125OD7737X
Rxcui197943
Spl Set Id38d8b457-0c0f-45cb-bf90-965c5a01b198
Manufacturer NamePreferred Pharmaceuticals Inc.

openFDA Package Details

Package NDCDescriptionMarketing startSample
68788-8867-330 TABLET, FILM COATED in 1 BOTTLE (68788-8867-3)2025-04-23No
68788-8867-660 TABLET, FILM COATED in 1 BOTTLE (68788-8867-6)2025-04-23No
68788-8867-990 TABLET, FILM COATED in 1 BOTTLE (68788-8867-9)2025-04-23No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
125OD7737XMETHOCARBAMOL532-03-6METHOCARBAMOL

Packages

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Methocarbamol Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2025-04-23HUMAN PRESCRIPTION DRUG LABEL1