Baclofen

Product NDC
60687-804
11-digit product format
606870804
Labeler code
60687
Product ID
60687-804_3b8a78f0-cf6e-1adb-e063-6294a90a55e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211659
Marketing category
ANDA
Marketing start
2024-05-26
Substance
BACLOFEN
Active strength
5 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
60687-804-656068708046550 BLISTER PACK in 1 CARTON (60687-804-65) / 1 TABLET in 1 BLISTER PACK (60687-804-11) 50 blister pack2024-05-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets, USP Rx Only 8480465/0525FAmerican Health Packaging2025-08-04HUMAN PRESCRIPTION DRUG LABEL4