FDA.reportPublic FDA data

Methocarbamol

Product NDC
68788-8213
11-digit product format
687888213
Labeler code
68788
Product ID
68788-8213_8eae2bcf-5789-4092-9f65-9f586f7591b6
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
2022-09-08
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
68788-8213-3Methocarbamol30 in 1 BOTTLETABLET, COATED304
68788-8213-6Methocarbamol60 in 1 BOTTLETABLET, COATED604
68788-8213-9Methocarbamol90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8213-3EA - Each68788-82130ea9d353-befa-4b23-b965-b3ead4cd5f8a12022-09-12
68788-8213-6EA - Each68788-821328f7bf3f-5478-4a90-96cf-18b102719a1212022-10-06
68788-8213-9EA - Each68788-82131dd4ebd7-6e6e-4b90-b357-bbbf623064d812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8213METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240716_e03878d3-d780-4e7f-b828-20ac2a109933.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNe03878d3-d780-4e7f-b828-20ac2a1099334
197943methocarbamol 500 MG Oral TabletSCDe03878d3-d780-4e7f-b828-20ac2a1099334

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8213-36878882130330 TABLET, COATED in 1 BOTTLE (68788-8213-3) 2022-09-080000-00-00NoNoCurrent
68788-8213-66878882130660 TABLET, COATED in 1 BOTTLE (68788-8213-6) 2022-09-080000-00-00NoNoCurrent
68788-8213-96878882130990 TABLET, COATED in 1 BOTTLE (68788-8213-9) 2022-09-080000-00-00NoNoCurrent