Metaxalone

Product NDC
64980-472
11-digit product format
649800472
Labeler code
64980
Product ID
64980-472_f256e874-703a-48a8-bae8-77c0b46a2968
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA208774
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
4fe1c2a6-5488-f909-3872-734054eb745aProduct name520181231
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4Product name120150615
68c52498-c9cb-48ab-a792-a4876149361eProduct name120150409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-472-01EA - Each64980-4722d489cfe-3404-446a-9e1b-19c520fe882812019-03-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNa37094c9-6941-da34-e053-2995a90a9c253
351254metaxalone 800 MG Oral TabletSCDa37094c9-6941-da34-e053-2995a90a9c253
351254metaxalone 800 MG Oral TabletPSN7cd2c31c-adf9-459f-9c52-7bbc5639767f2
351254metaxalone 800 MG Oral TabletSCD7cd2c31c-adf9-459f-9c52-7bbc5639767f2
351254metaxalone 800 MG Oral TabletPSN124f3ef7-17a4-b9a9-e063-6394a90afe151
351254metaxalone 800 MG Oral TabletPSNbc2cec64-f842-532c-e053-2995a90a554d1
351254metaxalone 800 MG Oral TabletSCD124f3ef7-17a4-b9a9-e063-6394a90afe151
351254metaxalone 800 MG Oral TabletSCDbc2cec64-f842-532c-e053-2995a90a554d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-472-0164980047201100 TABLET in 1 BOTTLE (64980-472-01) 100 tablet2018-09-240000-00-00NoNoCurrent
64980-472-5064980047250500 TABLET in 1 BOTTLE (64980-472-50) 500 tablet2018-09-240000-00-00NoNoCurrent