Metaxalone

Product NDC
55111-650
11-digit product format
551110650
Labeler code
55111
Product ID
55111-650_2c27dda6-06ef-c6ae-e063-6294a90a8ff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Limited
Application
ANDA207466
Marketing category
ANDA
Marketing start
2017-08-31
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metaxalone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METAXALONE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NMA9J598Y
Rxcui351254

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe1c2a6-5488-f909-3872-734054eb745aProduct name520181231
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4Product name120150615
68c52498-c9cb-48ab-a792-a4876149361eProduct name120150409

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-650-01Metaxalone100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-650METAXALONE TABLET [DR. REDDY’S LABORATORIES LIMITED]6Current NDC, Legacy NDC, 1 package rows20250121_02eb5938-cd59-4a81-853d-a4148d813a94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNedc6ba8d-2d45-4833-8dc7-e2d4e5d7285613
351254metaxalone 800 MG Oral TabletSCDedc6ba8d-2d45-4833-8dc7-e2d4e5d7285613
351254metaxalone 800 MG Oral TabletPSN02eb5938-cd59-4a81-853d-a4148d813a946
351254metaxalone 800 MG Oral TabletPSN8c1e10fe-0330-4bf8-a94d-aeed80f6aef16
351254metaxalone 800 MG Oral TabletSCD8c1e10fe-0330-4bf8-a94d-aeed80f6aef16
351254metaxalone 800 MG Oral TabletSCD02eb5938-cd59-4a81-853d-a4148d813a946
351254metaxalone 800 MG Oral TabletPSNb57fcd53-4481-4345-983c-23b7356a69ad5
351254metaxalone 800 MG Oral TabletSCDb57fcd53-4481-4345-983c-23b7356a69ad5
351254metaxalone 800 MG Oral TabletPSN686b8c39-4ed8-4d69-e053-2991aa0a579d4
351254metaxalone 800 MG Oral TabletPSN9c7d0cd4-625a-485e-9d13-ce854630148c4
351254metaxalone 800 MG Oral TabletSCD686b8c39-4ed8-4d69-e053-2991aa0a579d4
351254metaxalone 800 MG Oral TabletSCD9c7d0cd4-625a-485e-9d13-ce854630148c4
351254metaxalone 800 MG Oral TabletPSN8aa84e64-0075-4f22-a576-da085f32d56c3
351254metaxalone 800 MG Oral TabletSCD8aa84e64-0075-4f22-a576-da085f32d56c3
351254metaxalone 800 MG Oral TabletPSNf2b46d69-1c20-5ae9-e053-2a95a90a60a92
351254metaxalone 800 MG Oral TabletSCDf2b46d69-1c20-5ae9-e053-2a95a90a60a92
351254metaxalone 800 MG Oral TabletPSN36c1d263-48ce-831b-e063-6394a90a0a2b1
351254metaxalone 800 MG Oral TabletSCD36c1d263-48ce-831b-e063-6394a90a0a2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-650-0155111065001100 TABLET in 1 BOTTLE (55111-650-01) 100 tablet2017-08-310000-00-00NoNoCurrent