FDA.reportPublic FDA data

BACLOFEN

Product NDC
73320-003
11-digit product format
733200003
Labeler code
73320
Product ID
73320-003_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
20 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
73320-003-012025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-003-022025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-003-032025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only
73320-003-042025-01-30C16284748780-12cef2736-8d40-d83d-e063-dadaa90ab31fBACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73320-003-01BACLOFEN30 in 1 BOTTLETABLET302
73320-003-02BACLOFEN100 in 1 BOTTLETABLET1002
73320-003-03BACLOFEN500 in 1 BOTTLETABLET5002
73320-003-04BACLOFEN1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73320-003-02EA - Each73320-00398856baf-d536-4781-bc9c-5b4e213dc93512022-06-06
73320-003-03EA - Each73320-003de707adc-7daf-4de7-94df-7b5b5e98399812022-06-06
73320-003-04EA - Each73320-003c89ed7c6-bb7b-4757-93c2-02a33ad1aba512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73320-003BACLOFEN TABLET [KARTHA PHARMACEUTICALS, INC.]2Legacy NDC, 4 package rows20230112_13782442-bc11-4221-b5f0-46a9d1f06143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
197392baclofen 20 MG Oral TabletPSN129fd043-6641-cc46-e063-6294a90a6eae1
197392baclofen 20 MG Oral TabletPSN1bf59c3b-f8eb-972e-e063-6394a90aeccc1
197392baclofen 20 MG Oral TabletSCD129fd043-6641-cc46-e063-6294a90a6eae1
197392baclofen 20 MG Oral TabletSCD1bf59c3b-f8eb-972e-e063-6394a90aeccc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73320-003-017332000030130 TABLET in 1 BOTTLE (73320-003-01) 30 tablet2021-07-010000-00-00NoNoCurrent
73320-003-0273320000302100 TABLET in 1 BOTTLE (73320-003-02) 100 tablet2021-07-010000-00-00NoNoCurrent
73320-003-0373320000303500 TABLET in 1 BOTTLE (73320-003-03) 500 tablet2021-07-010000-00-00NoNoCurrent
73320-003-04733200003041000 TABLET in 1 BOTTLE (73320-003-04) 1000 tablet2021-07-010000-00-00NoNoCurrent