NDC 70511-121

Baclofen

Baclofen

Baclofen is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Mala Pharmaceuticals, Inc.. The primary component is Baclofen.

Product ID70511-121_7d9264f9-befc-4b43-9159-cca5d0eb0a05
NDC70511-121
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormInjection
Route of AdministrationINTRATHECAL
Marketing Start Date2021-04-02
Marketing CategoryANDA /
Application NumberANDA210777
Labeler NameMAlA Pharmaceuticals, Inc.
Substance NameBACLOFEN
Active Ingredient Strength50 ug/mL
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70511-121-83

5 CARTON in 1 CARTON (70511-121-83) > 1 SYRINGE, GLASS in 1 CARTON (70511-121-06) > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2021-04-02
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Baclofen" or generic name "Baclofen"

NDCBrand NameGeneric Name
0115-1010BaclofenBaclofen
0115-1011BaclofenBaclofen
0115-1012BaclofenBaclofen
0172-4096BaclofenBaclofen
0172-4097BaclofenBaclofen
0527-1330Baclofenbaclofen
0527-1333Baclofenbaclofen
0527-1337Baclofenbaclofen
0603-2406BaclofenBaclofen
0603-2407BaclofenBaclofen
0615-3541BaclofenBaclofen
0615-3542BaclofenBaclofen
0615-8411BaclofenBaclofen
0615-8412BaclofenBaclofen
68071-3075BaclofenBaclofen
68071-3001BaclofenBaclofen
68084-855BaclofenBaclofen
68084-868BaclofenBaclofen
68788-0522BaclofenBaclofen
68788-6903BaclofenBaclofen
68788-9246BaclofenBaclofen
68788-6384BaclofenBaclofen
68788-9735BaclofenBaclofen
68788-9796BaclofenBaclofen
68788-9846BaclofenBaclofen
70518-0215BaclofenBaclofen
70518-0362BaclofenBaclofen
70518-0411BaclofenBaclofen
70518-0547BaclofenBaclofen
70518-1515BaclofenBaclofen
70710-1285BaclofenBaclofen
70771-1449BaclofenBaclofen
70771-1448BaclofenBaclofen
70710-1286BaclofenBaclofen
71335-0206BaclofenBaclofen
71335-0344BaclofenBaclofen
71335-0103BaclofenBaclofen
71335-0949BACLOFENBACLOFEN
0832-1025BaclofenBaclofen
0832-1055BaclofenBaclofen
0832-1024BaclofenBaclofen
0832-1054BaclofenBaclofen
0904-5222BaclofenBaclofen
0904-3365BaclofenBaclofen
0904-6476BaclofenBaclofen
0904-6475BaclofenBaclofen
10135-533BaclofenBaclofen
10135-532BaclofenBaclofen
10544-172BaclofenBaclofen
16714-072BaclofenBaclofen

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.