NDC 70518-0720

BENZTROPINE MESYLATE

Benztropine Mesylate

BENZTROPINE MESYLATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Benztropine Mesylate.

Product ID70518-0720_78894e55-e8ad-62c1-e053-2a91aa0a2815
NDC70518-0720
Product TypeHuman Prescription Drug
Proprietary NameBENZTROPINE MESYLATE
Generic NameBenztropine Mesylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA090168
Labeler NameREMEDYREPACK INC.
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 Through2019-12-31

Packaging

NDC 70518-0720-0

30 TABLET in 1 BLISTER PACK (70518-0720-0)
Marketing Start Date2017-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0720-2 [70518072002]

BENZTROPINE MESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA090168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-16

NDC 70518-0720-0 [70518072000]

BENZTROPINE MESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA090168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

NDC 70518-0720-1 [70518072001]

BENZTROPINE MESYLATE TABLET
Marketing CategoryANDA
Application NumberANDA090168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

Drug Details

Active Ingredients

IngredientStrength
BENZTROPINE MESYLATE.5 mg/1

OpenFDA Data

SPL SET ID:b6446545-716d-4fdc-a054-6cdf468aae07
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 885219

    • Pharmacological Class

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