FDA.reportPublic FDA data

BACLOFEN

Product NDC
73320-002
11-digit product format
733200002
Labeler code
73320
Product ID
73320-002_21dc3dc4-c5a7-4075-95e9-64668dc205d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Kartha Pharmaceuticals, Inc.
Application
ANDA214374
Marketing category
ANDA
Marketing start
2021-07-01
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
10 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
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
73320-002-012025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-002-022025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-002-032025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-002-042025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-002-052025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73320-002-01BACLOFEN30 in 1 BOTTLETABLET302
73320-002-02BACLOFEN100 in 1 BOTTLETABLET1002
73320-002-03BACLOFEN500 in 1 BOTTLETABLET5002
73320-002-04BACLOFEN1000 in 1 BOTTLETABLET10002
73320-002-05BACLOFEN2500 in 1 BOTTLETABLET25002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73320-002BACLOFEN TABLET [KARTHA PHARMACEUTICALS, INC.]2Legacy NDC, 5 package rows20230112_13782442-bc11-4221-b5f0-46a9d1f06143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN96f9caa3-0d36-4d99-8c6f-0da5b0d03527100
197391baclofen 10 MG Oral TabletSCD96f9caa3-0d36-4d99-8c6f-0da5b0d03527100
197391baclofen 10 MG Oral TabletPSN13782442-bc11-4221-b5f0-46a9d1f061432
197392baclofen 20 MG Oral TabletPSN13782442-bc11-4221-b5f0-46a9d1f061432
430902baclofen 5 MG Oral TabletPSN13782442-bc11-4221-b5f0-46a9d1f061432
197391baclofen 10 MG Oral TabletSCD13782442-bc11-4221-b5f0-46a9d1f061432
197392baclofen 20 MG Oral TabletSCD13782442-bc11-4221-b5f0-46a9d1f061432
430902baclofen 5 MG Oral TabletSCD13782442-bc11-4221-b5f0-46a9d1f061432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73320-002-017332000020130 TABLET in 1 BOTTLE (73320-002-01) 30 tablet2021-07-010000-00-00NoNoCurrent
73320-002-0273320000202100 TABLET in 1 BOTTLE (73320-002-02) 100 tablet2021-07-010000-00-00NoNoCurrent
73320-002-0373320000203500 TABLET in 1 BOTTLE (73320-002-03) 500 tablet2021-07-010000-00-00NoNoCurrent
73320-002-04733200002041000 TABLET in 1 BOTTLE (73320-002-04) 1000 tablet2021-07-010000-00-00NoNoCurrent
73320-002-05733200002052500 TABLET in 1 BOTTLE (73320-002-05) 2500 tablet2021-07-010000-00-00NoNoCurrent