tolterodine tartrate

Generic: tolterodine tartrate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolterodine tartrate
Generic Name tolterodine tartrate
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tolterodine tartrate 1 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-097
Product ID 33342-097_fa641ff6-005b-47c5-bade-8709129d7ac9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203409
Listing Expiration 2026-12-31
Marketing Start 2020-10-08

Pharmacologic Class

Classes
cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342097
Hyphenated Format 33342-097

Supplemental Identifiers

RxCUI
855178 855194
UPC
0333342097095
UNII
5T619TQR3R

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 tolterodine tartrate (source: ndc)
Generic Name tolterodine tartrate (source: ndc)
Application Number ANDA203409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09)
  • 10 BLISTER PACK in 1 CARTON (33342-097-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15)
source: ndc

Packages (3)

33342-097-09 60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09) 33342-097-12 10 BLISTER PACK in 1 CARTON (33342-097-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-097-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15)

Ingredients (1)

tolterodine tartrate (1 mg/1)

Linked Drug Pages (1)

Tolterodine tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fa641ff6-005b-47c5-bade-8709129d7ac9", "openfda": {"upc": ["0333342097095"], "unii": ["5T619TQR3R"], "rxcui": ["855178", "855194"], "spl_set_id": ["3f2291c3-7e3c-41be-afa6-ef73ce896e30"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09)", "package_ndc": "33342-097-09", "marketing_start_date": "20201008"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-097-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-097-12", "marketing_start_date": "20201008"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15)", "package_ndc": "33342-097-15", "marketing_start_date": "20201008"}], "brand_name": "Tolterodine tartrate", "product_id": "33342-097_fa641ff6-005b-47c5-bade-8709129d7ac9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "33342-097", "generic_name": "Tolterodine tartrate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine tartrate", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA203409", "marketing_category": "ANDA", "marketing_start_date": "20201008", "listing_expiration_date": "20261231"}