FDA.reportPublic FDA data

Methocarbamol

Product NDC
43353-949
11-digit product format
433530949
Labeler code
43353
Product ID
43353-949_7e17be6b-c73d-48e1-8541-172078eff938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA200958
Marketing category
ANDA
Marketing start
2014-02-20
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
43353-949-532023-01-30C16284748780-1f386c649-a913-0266-e053-dadaa90a7c1aMethocarbamol tablet, film coated 750 mg
43353-949-602023-01-30C16284748780-1f386c649-a913-0266-e053-dadaa90a7c1aMethocarbamol tablet, film coated 750 mg
43353-949-702023-01-30C16284748780-1f386c649-a913-0266-e053-dadaa90a7c1aMethocarbamol tablet, film coated 750 mg
43353-949-802023-01-30C16284748780-1f386c649-a913-0266-e053-dadaa90a7c1aMethocarbamol tablet, film coated 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-949-53Methocarbamol60 in 1 BOTTLETABLET, FILM COATED602
43353-949-60Methocarbamol90 in 1 BOTTLETABLET, FILM COATED902
43353-949-70Methocarbamol120 in 1 BOTTLETABLET, FILM COATED1202
43353-949-80Methocarbamol180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-949-53EA - Each43353-949011488ac-25df-44cb-9fdb-5dfbc4d7cca112016-07-19
43353-949-60EA - Each43353-949c44493ee-2151-4d00-859e-83e3b06813a912016-07-19
43353-949-70EA - Each43353-9491d263d40-40f6-4a48-bb27-a33f64f2c96912016-07-19
43353-949-80EA - Each43353-9496f2b6d40-663a-41a9-9211-32f0711a375812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-949METHOCARBAMOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20191221_12c38732-92fb-49e2-8b13-8844b3a58670.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN12c38732-92fb-49e2-8b13-8844b3a586702
197944methocarbamol 750 MG Oral TabletSCD12c38732-92fb-49e2-8b13-8844b3a586702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-949-534335309495360 TABLET, FILM COATED in 1 BOTTLE (43353-949-53) 2014-06-090000-00-00NoNoCurrent
43353-949-604335309496090 TABLET, FILM COATED in 1 BOTTLE (43353-949-60) 2014-06-070000-00-00NoNoCurrent
43353-949-7043353094970120 TABLET, FILM COATED in 1 BOTTLE (43353-949-70) 2014-08-010000-00-00NoNoCurrent
43353-949-8043353094980180 TABLET, FILM COATED in 1 BOTTLE (43353-949-80) 2014-08-010000-00-00NoNoCurrent