benztropine mesylate

Generic: benztropine mesylate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate 1 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0577
Product ID 70518-0577_4aa441eb-8d69-bc65-e063-6294a90a5969
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090168
Listing Expiration 2027-12-31
Marketing Start 2017-06-19

Pharmacologic Class

Classes
anticholinergic [epc] antihistamine [epc] cholinergic antagonists [moa] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180577
Hyphenated Format 70518-0577

Supplemental Identifiers

RxCUI
885213
UNII
WMJ8TL7510

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benztropine mesylate (source: ndc)
Generic Name benztropine mesylate (source: ndc)
Application Number ANDA090168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-0577-2)
  • 100 POUCH in 1 BOX (70518-0577-3) / 1 TABLET in 1 POUCH (70518-0577-4)
  • 100 POUCH in 1 BOX (70518-0577-5) / 1 TABLET in 1 POUCH (70518-0577-6)
source: ndc

Packages (3)

70518-0577-2 30 TABLET in 1 BLISTER PACK (70518-0577-2) 70518-0577-3 100 POUCH in 1 BOX (70518-0577-3) / 1 TABLET in 1 POUCH (70518-0577-4) 70518-0577-5 100 POUCH in 1 BOX (70518-0577-5) / 1 TABLET in 1 POUCH (70518-0577-6)

Ingredients (1)

benztropine mesylate (1 mg/1)

Linked Drug Pages (1)

BENZTROPINE MESYLATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4aa441eb-8d69-bc65-e063-6294a90a5969", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885213"], "spl_set_id": ["01688e6f-7b22-41bf-9a85-1c88d90f99b6"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-0577-2)", "package_ndc": "70518-0577-2", "marketing_start_date": "20200609"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-0577-3)  / 1 TABLET in 1 POUCH (70518-0577-4)", "package_ndc": "70518-0577-3", "marketing_start_date": "20220203"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-0577-5)  / 1 TABLET in 1 POUCH (70518-0577-6)", "package_ndc": "70518-0577-5", "marketing_start_date": "20260123"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "70518-0577_4aa441eb-8d69-bc65-e063-6294a90a5969", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70518-0577", "generic_name": "BENZTROPINE MESYLATE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZTROPINE MESYLATE", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "1 mg/1"}], "application_number": "ANDA090168", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20271231"}