FDA.reportPublic FDA data

Methocarbamol

Product NDC
68071-4520
11-digit product format
680714520
Labeler code
68071
Product ID
68071-4520_49a0a91a-ad87-d1f7-e063-6294a90a6bcc
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
500 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4520-22024-06-10C16284748780-1ba0f9c33-177c-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only
68071-4520-32024-06-10C16284748780-1ba0f9c33-177c-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only
68071-4520-22021-01-29C16284748780-1ba0f9c33-177c-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only
68071-4520-32021-01-29C16284748780-1ba0f9c33-177c-a910-e053-dadaa90a0b85Methocarbamol Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4520-2Methocarbamol20 in 1 BOTTLETABLET, COATED206
68071-4520-3Methocarbamol30 in 1 BOTTLETABLET, COATED306
68071-4520-6Methocarbamol60 in 1 BOTTLETABLET, COATED606
68071-4520-9Methocarbamol90 in 1 BOTTLETABLET, COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4520METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 4 package rows20250116_72f36d28-15d2-30f6-e053-2a91aa0ad1ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN72f36d28-15d2-30f6-e053-2a91aa0ad1ce6
197943methocarbamol 500 MG Oral TabletSCD72f36d28-15d2-30f6-e053-2a91aa0ad1ce6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-4520-26807145200220 TABLET, COATED in 1 BOTTLE (68071-4520-2) 2018-08-08NoNoCurrent
68071-4520-36807145200330 TABLET, COATED in 1 BOTTLE (68071-4520-3) 2018-08-08NoNoCurrent
68071-4520-66807145200660 TABLET, COATED in 1 BOTTLE (68071-4520-6) 2025-01-14NoNoCurrent
68071-4520-96807145200990 TABLET, COATED in 1 BOTTLE (68071-4520-9) 2026-01-30NoNoCurrent