FDA.reportPublic FDA data

Baclofen

Product NDC
71610-391
11-digit product format
716100391
Labeler code
71610
Product ID
71610-391_9426da49-2adb-4bda-b1e8-6122a1886bba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077068
Marketing category
ANDA
Marketing start
2005-08-30
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
2021-12-31
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
71610-391-452023-01-30C16284748780-1f386c649-c5e0-0266-e053-dadaa90a7c1aBaclofen Tablets, USP
71610-391-602023-01-30C16284748780-1f386c649-c5e0-0266-e053-dadaa90a7c1aBaclofen Tablets, USP
71610-391-922023-01-30C16284748780-1f386c649-c5e0-0266-e053-dadaa90a7c1aBaclofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-391-45Baclofen45 in 1 BOTTLE, PLASTICTABLET451
71610-391-60Baclofen90 in 1 BOTTLE, PLASTICTABLET901
71610-391-92Baclofen270 in 1 BOTTLE, PLASTICTABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-391-45EA - Each71610-39158404027-f126-4e49-9cc4-c2f2af1f278412020-03-10
71610-391-60EA - Each71610-391a274098d-2bcd-4c2a-8c10-e3371fe149c312020-03-10
71610-391-92EA - Each71610-39135cb056d-28c7-4911-a04f-ebbc27049b3d12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-391BACLOFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20200225_f0603733-ecaa-4e4d-a409-4a1599f54700.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNf0603733-ecaa-4e4d-a409-4a1599f547001
197392baclofen 20 MG Oral TabletSCDf0603733-ecaa-4e4d-a409-4a1599f547001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-391-457161003914545 TABLET in 1 BOTTLE, PLASTIC (71610-391-45) 45 tablet2020-01-240000-00-00NoNoCurrent
71610-391-607161003916090 TABLET in 1 BOTTLE, PLASTIC (71610-391-60) 90 tablet2020-01-240000-00-00NoNoCurrent
71610-391-9271610039192270 TABLET in 1 BOTTLE, PLASTIC (71610-391-92) 270 tablet2020-01-240000-00-00NoNoCurrent