FDA.reportPublic FDA data

Baclofen

Product NDC
31722-138
11-digit product format
317220138
Labeler code
31722
Product ID
31722-138_896572e4-f389-4b66-9a0b-4b83e71481b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
5 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
2022-12-31
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
31722-138-012026-01-29C16284748780-1f386c649-aeb1-0266-e053-dadaa90a7c1aBaclofen Tablets, USP Rx only
31722-138-102026-01-29C16284748780-1f386c649-aeb1-0266-e053-dadaa90a7c1aBaclofen Tablets, USP Rx only
31722-138-012023-10-11C16284748780-1f386c649-aeb1-0266-e053-dadaa90a7c1aBaclofen Tablets, USP Rx only
31722-138-102023-10-11C16284748780-1f386c649-aeb1-0266-e053-dadaa90a7c1aBaclofen Tablets, USP Rx only
31722-138-012023-01-30C16284748780-1f386c649-aeb1-0266-e053-dadaa90a7c1aBaclofen Tablets, USP Rx only
31722-138-102023-01-30C16284748780-1f386c649-aeb1-0266-e053-dadaa90a7c1aBaclofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-138-01Baclofen100 in 1 BOTTLETABLET1003
31722-138-10Baclofen1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-138-01EA - Each31722-138f47bffbe-4aa3-4ee7-843b-d326babba18612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-138BACLOFEN TABLET [CAMBER PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20231012_ce48b5de-92d3-424e-ba70-c1f2edb28f66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNce48b5de-92d3-424e-ba70-c1f2edb28f663
197392baclofen 20 MG Oral TabletPSNce48b5de-92d3-424e-ba70-c1f2edb28f663
430902baclofen 5 MG Oral TabletPSNce48b5de-92d3-424e-ba70-c1f2edb28f663
197391baclofen 10 MG Oral TabletSCDce48b5de-92d3-424e-ba70-c1f2edb28f663
197392baclofen 20 MG Oral TabletSCDce48b5de-92d3-424e-ba70-c1f2edb28f663
430902baclofen 5 MG Oral TabletSCDce48b5de-92d3-424e-ba70-c1f2edb28f663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-138-0131722013801100 TABLET in 1 BOTTLE (31722-138-01) 100 tablet2020-10-150000-00-00NoNoCurrent
31722-138-10317220138101000 TABLET in 1 BOTTLE (31722-138-10) 1000 tablet2020-10-150000-00-00NoNoCurrent