FDA.reportPublic FDA data

Baclofen

Product NDC
52959-677
11-digit product format
529590677
Labeler code
52959
Product ID
52959-677_0d3ec116-a621-4f15-bc56-c63487a319bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA072235
Marketing category
ANDA
Marketing start
2010-07-15
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 mg/1
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-677-022019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-677-102019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-677-302019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-677-452019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-677-602019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-677-902019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-677-02Baclofen120 in 1 BOTTLETABLET1202
52959-677-10Baclofen10 in 1 BOTTLETABLET102
52959-677-30Baclofen30 in 1 BOTTLETABLET302
52959-677-45Baclofen45 in 1 BOTTLETABLET452
52959-677-60Baclofen60 in 1 BOTTLETABLET602
52959-677-90Baclofen90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-677BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 6 package rows20111214_962601f8-7567-4afe-90a0-6df356f5a297.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN962601f8-7567-4afe-90a0-6df356f5a2972
197392baclofen 20 MG Oral TabletPSN962601f8-7567-4afe-90a0-6df356f5a2972
197391baclofen 10 MG Oral TabletSCD962601f8-7567-4afe-90a0-6df356f5a2972
197392baclofen 20 MG Oral TabletSCD962601f8-7567-4afe-90a0-6df356f5a2972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-677-0252959067702120 in 1 BOTTLEHistorical
52959-677-105295906771010 in 1 BOTTLEHistorical
52959-677-305295906773030 in 1 BOTTLEHistorical
52959-677-455295906774545 in 1 BOTTLEHistorical
52959-677-605295906776060 in 1 BOTTLEHistorical
52959-677-905295906779090 in 1 BOTTLEHistorical