FDA.reportPublic FDA data

Methocarbamol

Product NDC
35561-349
11-digit product format
355610349
Labeler code
35561
Product ID
35561-349_49fcc548-27fe-58d0-e063-6294a90af96d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bostal LLC
Application
ANDA200958
Marketing category
ANDA
Marketing start
2022-07-16
Substance
METHOCARBAMOL
Active strength
1000 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
METHOCARBAMOL1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943, 197944, 2611794

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
35561-349-12Methocarbamol100 in 1 BOTTLE, PLASTICTABLET, COATED1008
35561-349-13Methocarbamol500 in 1 BOTTLE, PLASTICTABLET, COATED5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-349METHOCARBAMOL TABLET, COATED [AUSTARPHARMA LLC]7Current NDC, 2 package rows20240807_d8f10211-f96e-4cf3-9b49-986eb51b703d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2611794methocarbamol 1000 MG Oral TabletPSNd8f10211-f96e-4cf3-9b49-986eb51b703d8
197943methocarbamol 500 MG Oral TabletPSNd8f10211-f96e-4cf3-9b49-986eb51b703d8
197944methocarbamol 750 MG Oral TabletPSNd8f10211-f96e-4cf3-9b49-986eb51b703d8
2611794methocarbamol 1000 MG Oral TabletSCDd8f10211-f96e-4cf3-9b49-986eb51b703d8
197943methocarbamol 500 MG Oral TabletSCDd8f10211-f96e-4cf3-9b49-986eb51b703d8
197944methocarbamol 750 MG Oral TabletSCDd8f10211-f96e-4cf3-9b49-986eb51b703d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
35561-349-1235561034912100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-12) 2022-07-16NoNoCurrent
35561-349-1335561034913500 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-13) 2022-07-16NoNoCurrent