NDC 0115-1012

Baclofen

Baclofen

Baclofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Baclofen.

Product ID0115-1012_4ff52a41-574a-4994-9024-8e492530b93f
NDC0115-1012
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-10-27
Marketing CategoryANDA / ANDA
Application NumberANDA077971
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameBACLOFEN
Active Ingredient Strength20 mg/1
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0115-1012-01

100 TABLET in 1 BOTTLE (0115-1012-01)
Marketing Start Date2007-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1012-03 [00115101203]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-27

NDC 0115-1012-02 [00115101202]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-27

NDC 0115-1012-01 [00115101201]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-27

NDC 0115-1012-08 [00115101208]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-27

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN20 mg/1

Pharmacological Class

  • GABA A Agonists [MoA]
  • GABA B Agonists [MoA]
  • gamma-Aminobutyric Acid-ergic Agonist [EPC]

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
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