FDA.reportPublic FDA data

METHOCARBAMOL

Product NDC
61919-368
11-digit product format
619190368
Labeler code
61919
Product ID
61919-368_47e1580c-5da2-4f45-e063-6294a90ab181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHOCARBAMOL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090200
Marketing category
ANDA
Marketing start
2019-04-18
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, 197944

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
61919-368-07METHOCARBAMOL7 in 1 BOTTLETABLET716
61919-368-30METHOCARBAMOL30 in 1 BOTTLETABLET3016
61919-368-40METHOCARBAMOL40 in 1 BOTTLETABLET4016
61919-368-60METHOCARBAMOL60 in 1 BOTTLETABLET6016
61919-368-90METHOCARBAMOL90 in 1 BOTTLETABLET9016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-368METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECT RX]15Current NDC, Legacy NDC, 5 package rows20240915_31508051-c9cb-149b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN31508051-c9cb-149b-e054-00144ff88e8816
197944methocarbamol 750 MG Oral TabletPSN31508051-c9cb-149b-e054-00144ff88e8816
197943methocarbamol 500 MG Oral TabletSCD31508051-c9cb-149b-e054-00144ff88e8816
197944methocarbamol 750 MG Oral TabletSCD31508051-c9cb-149b-e054-00144ff88e8816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-368-07619190368077 TABLET in 1 BOTTLE (61919-368-07) 7 tablet2019-04-180000-00-00NoNoCurrent
61919-368-306191903683030 TABLET in 1 BOTTLE (61919-368-30) 30 tablet2019-04-180000-00-00NoNoCurrent
61919-368-406191903684040 TABLET in 1 BOTTLE (61919-368-40) 40 tablet2019-04-180000-00-00NoNoCurrent
61919-368-606191903686060 TABLET in 1 BOTTLE (61919-368-60) 60 tablet2019-04-180000-00-00NoNoCurrent
61919-368-906191903689090 TABLET in 1 BOTTLE (61919-368-90) 90 tablet2019-04-180000-00-00NoNoCurrent