benztropine mesylate

Generic: benztropine

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

Drug Facts

Product Profile

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

benztropine mesylate 2 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-832
Product ID 69097-832_3d362141-de53-4949-b9a5-34f2b7bb0e75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090294
Listing Expiration 2026-12-31
Marketing Start 2016-06-29

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 69097832
Hyphenated Format 69097-832

Supplemental Identifiers

RxCUI
885209 885213 885219
UPC
0369097826079 0369097827076 0369097832070
UNII
WMJ8TL7510

Packaging Origin

Original Packager
true

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 (source: ndc)
Application Number ANDA090294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-832-02)
  • 100 TABLET in 1 BOTTLE (69097-832-07)
  • 1000 TABLET in 1 BOTTLE (69097-832-15)
source: ndc

Packages (3)

69097-832-02 30 TABLET in 1 BOTTLE (69097-832-02) 69097-832-07 100 TABLET in 1 BOTTLE (69097-832-07) 69097-832-15 1000 TABLET in 1 BOTTLE (69097-832-15)

Ingredients (1)

benztropine mesylate (2 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": "3d362141-de53-4949-b9a5-34f2b7bb0e75", "openfda": {"upc": ["0369097826079", "0369097827076", "0369097832070"], "unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["3d2732f9-b8a9-4e83-91e7-da616ddcb786"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-832-02)", "package_ndc": "69097-832-02", "marketing_start_date": "20160629"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-832-07)", "package_ndc": "69097-832-07", "marketing_start_date": "20160629"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69097-832-15)", "package_ndc": "69097-832-15", "marketing_start_date": "20160629"}], "brand_name": "Benztropine Mesylate", "product_id": "69097-832_3d362141-de53-4949-b9a5-34f2b7bb0e75", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "69097-832", "generic_name": "Benztropine", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benztropine Mesylate", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "2 mg/1"}], "application_number": "ANDA090294", "marketing_category": "ANDA", "marketing_start_date": "20160629", "listing_expiration_date": "20261231"}