tolterodine tartrate extended release

Generic: tolterodine tartrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tolterodine tartrate extended release
Generic Name tolterodine tartrate
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tolterodine tartrate 4 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0048
Product ID 59762-0048_41ea8bd1-9374-41a1-8a14-f77ec72f0273
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021228
Marketing Start 2014-12-30
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 597620048
Hyphenated Format 59762-0048

Supplemental Identifiers

RxCUI
855182 855189
UPC
0359762004710
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 extended release (source: ndc)
Generic Name tolterodine tartrate (source: ndc)
Application Number NDA021228 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-1)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-2)
source: ndc

Packages (2)

59762-0048-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-1) 59762-0048-2 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-2)

Ingredients (1)

tolterodine tartrate (4 mg/1)

Linked Drug Pages (1)

Tolterodine Tartrate Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41ea8bd1-9374-41a1-8a14-f77ec72f0273", "openfda": {"upc": ["0359762004710"], "unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["0565f75a-3f4f-436e-930e-c31c6fa2b1e7"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-1)", "package_ndc": "59762-0048-1", "marketing_end_date": "20260531", "marketing_start_date": "20141230"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-2)", "package_ndc": "59762-0048-2", "marketing_end_date": "20260731", "marketing_start_date": "20141230"}], "brand_name": "Tolterodine Tartrate Extended Release", "product_id": "59762-0048_41ea8bd1-9374-41a1-8a14-f77ec72f0273", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "59762-0048", "generic_name": "tolterodine tartrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine Tartrate Extended Release", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "4 mg/1"}], "application_number": "NDA021228", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260731", "marketing_start_date": "20141230"}