Baclofen

Product NDC
68071-5252
11-digit product format
680715252
Labeler code
68071
Product ID
68071-5252_d77296ec-2678-cf6c-e053-2a95a90ac08f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211555
Marketing category
ANDA
Marketing start
2020-01-10
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5252-32022-02-07C16284748780-1d6a99b39-7125-a426-e053-dadaa90af4c2a512147f-34a2-49c6-e053-2a95a90aad8e
68071-5252-32022-01-28C16284748780-1d6a99b39-7125-a426-e053-dadaa90af4c2a512147f-34a2-49c6-e053-2a95a90aad8e

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5252BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC20250126_a512147f-34a2-49c6-e053-2a95a90aad8e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5252-36807152520330 TABLET in 1 BOTTLE (68071-5252-3) 30 tablet2020-05-070000-00-00NoNoCurrent