FDA.reportPublic FDA data

Methocarbamol

Product NDC
68788-8172
11-digit product format
687888172
Labeler code
68788
Product ID
68788-8172_b34ce0b6-6710-4137-b564-8d51c13adb6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2022-04-25
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
68788-8172-3Methocarbamol30 in 1 BOTTLETABLET, COATED304
68788-8172-6Methocarbamol60 in 1 BOTTLETABLET, COATED604
68788-8172-9Methocarbamol90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8172-3EA - Each68788-8172f7c5bd62-282d-4374-a865-6c9629105fbb12022-07-06
68788-8172-6EA - Each68788-81723c08d781-1ebb-4292-915d-732706e2d3bf12022-07-06
68788-8172-9EA - Each68788-8172066f81a0-6861-4478-91c8-fd427dd8096b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8172METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240716_43f83b87-e169-46fe-98bd-6af373595bd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN43f83b87-e169-46fe-98bd-6af373595bd34
197944methocarbamol 750 MG Oral TabletSCD43f83b87-e169-46fe-98bd-6af373595bd34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8172-36878881720330 TABLET, COATED in 1 BOTTLE (68788-8172-3) 2022-04-250000-00-00NoNoCurrent
68788-8172-66878881720660 TABLET, COATED in 1 BOTTLE (68788-8172-6) 2022-04-250000-00-00NoNoCurrent
68788-8172-96878881720990 TABLET, COATED in 1 BOTTLE (68788-8172-9) 2022-04-250000-00-00NoNoCurrent