Baclofen

Product NDC
68071-2420
11-digit product format
680712420
Labeler code
68071
Product ID
68071-2420_c33e8e72-f879-5884-e053-2995a90a82e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2420-32023-01-30C16284748780-1f386c64a-33a8-0266-e053-dadaa90a7c1ac33e8e72-f878-5884-e053-2995a90a82e8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2420BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210527_c33e8e72-f878-5884-e053-2995a90a82e8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2420-3680712420033 TABLET in 1 BOTTLE (68071-2420-3) 3 tablet2021-05-060000-00-00NoNoCurrent