FDA.reportPublic FDA data

Methocarbamol

Product NDC
85766-060
11-digit product format
857660060
Labeler code
85766
Product ID
85766-060_4e912acb-600b-b342-e063-6394a90a4b4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA213967
Marketing category
ANDA
Marketing start
2020-08-12
Substance
METHOCARBAMOL
Active strength
750 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
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
85766-060-01Methocarbamol100 in 1 BOTTLETABLET, FILM COATED1002
85766-060-05Methocarbamol500 in 1 BOTTLETABLET, FILM COATED5002
85766-060-21Methocarbamol21 in 1 BOTTLETABLET, FILM COATED212
85766-060-28Methocarbamol28 in 1 BOTTLETABLET, FILM COATED282
85766-060-30Methocarbamol30 in 1 BOTTLETABLET, FILM COATED302
85766-060-42Methocarbamol42 in 1 BOTTLETABLET, FILM COATED422
85766-060-60Methocarbamol60 in 1 BOTTLETABLET, FILM COATED602
85766-060-90Methocarbamol90 in 1 BOTTLETABLET, FILM COATED902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN64a06ef2-a062-49cc-9526-03c22b6ced2c2
197944methocarbamol 750 MG Oral TabletSCD64a06ef2-a062-49cc-9526-03c22b6ced2c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-060-0185766006001100 TABLET, FILM COATED in 1 BOTTLE (85766-060-01) 2025-08-29NoNoHistorical
85766-060-0585766006005500 TABLET, FILM COATED in 1 BOTTLE (85766-060-05) 2025-08-29NoNoHistorical
85766-060-218576600602121 TABLET, FILM COATED in 1 BOTTLE (85766-060-21) 2026-04-03NoNoHistorical
85766-060-288576600602828 TABLET, FILM COATED in 1 BOTTLE (85766-060-28) 2025-08-29NoNoHistorical
85766-060-308576600603030 TABLET, FILM COATED in 1 BOTTLE (85766-060-30) 2025-08-29NoNoHistorical
85766-060-428576600604242 TABLET, FILM COATED in 1 BOTTLE (85766-060-42) 2025-08-29NoNoHistorical
85766-060-608576600606060 TABLET, FILM COATED in 1 BOTTLE (85766-060-60) 2025-08-29NoNoHistorical
85766-060-908576600609090 TABLET, FILM COATED in 1 BOTTLE (85766-060-90) 2025-08-29NoNoHistorical