Baclofen

Product NDC
70518-3115
11-digit product format
705183115
Labeler code
70518
Product ID
70518-3115_c6617887-c793-2042-e053-2a95a90aa90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212378
Marketing category
ANDA
Marketing start
2021-06-09
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3115BACLOFEN TABLET [REMEDYREPACK INC.]5Legacy NDC20240926_6274e70a-fb57-461b-b1bc-39d4ff916b2a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3115-07051831150090 TABLET in 1 BOTTLE, PLASTIC (70518-3115-0) 90 tablet2021-06-090000-00-00NoNoCurrent
70518-3115-17051831150130 TABLET in 1 BLISTER PACK (70518-3115-1) 30 tablet2021-07-010000-00-00NoNoCurrent