FDA.reportPublic FDA data

Methocarbamol

Product NDC
68071-4505
11-digit product format
680714505
Labeler code
68071
Product ID
68071-4505_526ae47d-9369-9996-e063-6394a90a151a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4505-12021-02-17C16284748780-1ba0f9c33-1bce-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only
68071-4505-22021-02-17C16284748780-1ba0f9c33-1bce-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only
68071-4505-12021-01-29C16284748780-1ba0f9c33-1bce-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only
68071-4505-22021-01-29C16284748780-1ba0f9c33-1bce-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4505-1Methocarbamol21 in 1 BOTTLETABLET, COATED218
68071-4505-2Methocarbamol20 in 1 BOTTLETABLET, COATED208
68071-4505-3Methocarbamol30 in 1 BOTTLETABLET, COATED308
68071-4505-6Methocarbamol60 in 1 BOTTLETABLET, COATED608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4505METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 4 package rows20240612_71c21226-cd96-33ed-e053-2995a90a5269.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN71c21226-cd96-33ed-e053-2995a90a52698
197944methocarbamol 750 MG Oral TabletSCD71c21226-cd96-33ed-e053-2995a90a52698

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4505-16807145050121 TABLET, COATED in 1 BOTTLE (68071-4505-1) 2018-07-240000-00-00NoNoCurrent
68071-4505-26807145050220 TABLET, COATED in 1 BOTTLE (68071-4505-2) 2018-07-240000-00-00NoNoCurrent
68071-4505-36807145050330 TABLET, COATED in 1 BOTTLE (68071-4505-3) 2022-05-250000-00-00NoNoCurrent
68071-4505-66807145050660 TABLET, COATED in 1 BOTTLE (68071-4505-6) 2018-07-240000-00-00NoNoCurrent