BACLOFEN

Product NDC
71335-2497
11-digit product format
713352497
Labeler code
71335
Product ID
71335-2497_3677e29b-ef5f-459f-a9f0-b74a91b32924
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214374
Marketing category
ANDA
Marketing start
2024-03-01
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
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
71335-2497-071335249700120 TABLET in 1 BOTTLE (71335-2497-0) 120 tablet2024-09-16NoNoHistorical
71335-2497-17133524970190 TABLET in 1 BOTTLE (71335-2497-1) 90 tablet2024-09-16NoNoHistorical
71335-2497-27133524970220 TABLET in 1 BOTTLE (71335-2497-2) 20 tablet2024-09-16NoNoHistorical
71335-2497-37133524970360 TABLET in 1 BOTTLE (71335-2497-3) 60 tablet2024-09-16NoNoHistorical
71335-2497-47133524970445 TABLET in 1 BOTTLE (71335-2497-4) 45 tablet2024-09-16NoNoHistorical
71335-2497-571335249705112 TABLET in 1 BOTTLE (71335-2497-5) 112 tablet2024-09-16NoNoHistorical
71335-2497-67133524970630 TABLET in 1 BOTTLE (71335-2497-6) 30 tablet2024-09-16NoNoHistorical
71335-2497-77133524970756 TABLET in 1 BOTTLE (71335-2497-7) 56 tablet2024-09-16NoNoHistorical
71335-2497-87133524970815 TABLET in 1 BOTTLE (71335-2497-8) 15 tablet2024-09-16NoNoHistorical
71335-2497-97133524970984 TABLET in 1 BOTTLE (71335-2497-9) 84 tablet2024-09-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BACLOFEN TABLETS, USP Rx onlyBryant Ranch Prepack2024-09-16HUMAN PRESCRIPTION DRUG LABEL1