tolterodine tartrate

Generic: tolterodine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolterodine tartrate
Generic Name tolterodine
Labeler major pharmaceuticals
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tolterodine tartrate 4 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6593
Product ID 0904-6593_15347509-36ce-4dfc-91e3-9e41f06aa50a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203016
Marketing Start 2015-08-11
Marketing End 2026-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046593
Hyphenated Format 0904-6593

Supplemental Identifiers

RxCUI
855182 855189
UNII
5T619TQR3R

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 (source: ndc)
Application Number ANDA203016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6593-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6593-04 30 BLISTER PACK in 1 CARTON (0904-6593-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

tolterodine tartrate (4 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": "15347509-36ce-4dfc-91e3-9e41f06aa50a", "openfda": {"unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["da9423b5-00ab-46fc-8959-3db3c0a0bc6d"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6593-04)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6593-04", "marketing_end_date": "20260731", "marketing_start_date": "20150811"}], "brand_name": "TOLTERODINE TARTRATE", "product_id": "0904-6593_15347509-36ce-4dfc-91e3-9e41f06aa50a", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0904-6593", "generic_name": "TOLTERODINE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLTERODINE TARTRATE", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "4 mg/1"}], "application_number": "ANDA203016", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20150811"}