FDA.reportPublic FDA data

Metaxalone

Product NDC
70332-330
11-digit product format
703320330
Labeler code
70332
Product ID
70332-330_61ceb7b5-843b-1166-e053-2a91aa0a3982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
California Pharmaceuticals, LLC
Application
ANDA204770
Marketing category
ANDA
Marketing start
2017-08-04
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70332-330-012020-01-31C16284748780-19d75b9d1-1e1e-f424-e053-dadaa90a57ceMetaxalone Tablets, USP Repackaged RX Only
70332-330-022020-01-31C16284748780-19d75b9d1-1e1e-f424-e053-dadaa90a57ceMetaxalone Tablets, USP Repackaged RX Only
70332-330-032020-01-31C16284748780-19d75b9d1-1e1e-f424-e053-dadaa90a57ceMetaxalone Tablets, USP Repackaged RX Only
70332-330-042020-01-31C16284748780-19d75b9d1-1e1e-f424-e053-dadaa90a57ceMetaxalone Tablets, USP Repackaged RX Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70332-330-01EA - Each70332-3303e35a3e8-8a24-4687-b174-e1c6f4c59e6512017-09-11
70332-330-03EA - Each70332-330672916e8-3d4c-4213-b9c9-df6a6b0513d212017-11-06
70332-330-04EA - Each70332-330a8277498-754c-4870-bb29-5d3b80efc31812018-02-20