Baclofen

Product NDC
72162-2449
11-digit product format
721622449
Labeler code
72162
Product ID
72162-2449_a1fceea4-b11e-4fbd-8ae4-75eb79e0b32d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212067
Marketing category
ANDA
Marketing start
2020-07-09
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
H789N3FKE8BACLOFEN1134-47-0BACLOFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2449-0721622449001000 TABLET in 1 BOTTLE (72162-2449-0) 1000 tablet2025-01-22NoNoHistorical
72162-2449-172162244901100 TABLET in 1 BOTTLE (72162-2449-1) 100 tablet2025-01-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BaclofenBryant Ranch Prepack2025-01-22HUMAN PRESCRIPTION DRUG LABEL100