NDC 0904-6790

Benztropine Mesylate

Benztropine Mesylate

Benztropine Mesylate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Benztropine Mesylate.

Product ID0904-6790_ba090e3e-f6f1-4313-b0be-83687d9a7579
NDC0904-6790
Product TypeHuman Prescription Drug
Proprietary NameBenztropine Mesylate
Generic NameBenztropine Mesylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA204713
Labeler NameMajor Pharmaceuticals
Substance NameBENZTROPINE MESYLATE
Active Ingredient Strength1 mg/1
Pharm ClassesAnticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6790-61

100 BLISTER PACK in 1 CARTON (0904-6790-61) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6790-61 [00904679061]

Benztropine Mesylate TABLET
Marketing CategoryANDA
Application NumberANDA204713
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
BENZTROPINE MESYLATE1 mg/1

OpenFDA Data

SPL SET ID:fdbedfec-c19c-454b-8b0d-1952e59832ac
Manufacturer
UNII

Pharmacological Class

  • Anticholinergic [EPC]
  • Antihistamine [EPC]
  • Cholinergic Antagonists [MoA]
  • Histamine Receptor Antagonists [MoA]