benztropine mesylate

Generic: benztropine mesylate

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

Drug Facts

Product Profile

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

benztropine mesylate 2 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0603-2435
Product ID 0603-2435_f572eba2-cce7-4e65-9df4-9c0585530c0b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040715
Listing Expiration 2026-12-31
Marketing Start 2022-03-17

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 06032435
Hyphenated Format 0603-2435

Supplemental Identifiers

RxCUI
885209 885213 885219
UPC
0306032434210 0306032433213
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 mesylate (source: ndc)
Application Number ANDA040715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32)
source: ndc

Packages (2)

0603-2435-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21) 0603-2435-32 1000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32)

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": "f572eba2-cce7-4e65-9df4-9c0585530c0b", "openfda": {"upc": ["0306032434210", "0306032433213"], "unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["c19664aa-a797-4192-b5f3-e906a7cac048"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21)", "package_ndc": "0603-2435-21", "marketing_start_date": "20220317"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32)", "package_ndc": "0603-2435-32", "marketing_start_date": "20220317"}], "brand_name": "Benztropine Mesylate", "product_id": "0603-2435_f572eba2-cce7-4e65-9df4-9c0585530c0b", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0603-2435", "generic_name": "benztropine mesylate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benztropine Mesylate", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "2 mg/1"}], "application_number": "ANDA040715", "marketing_category": "ANDA", "marketing_start_date": "20220317", "listing_expiration_date": "20261231"}