tolterodine tartrate

Generic: tolterodine tartrate

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tolterodine tartrate 4 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-161
Product ID 70436-161_44e07d95-cc64-cae9-e063-6294a90abc45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213858
Listing Expiration 2026-12-31
Marketing Start 2021-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70436161
Hyphenated Format 70436-161

Supplemental Identifiers

RxCUI
855182 855189
UPC
0370436160020 0370436160068 0370436161041 0370436160044 0370436161027 0370436161065
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 ANDA213858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-02)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-04)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-06)
source: ndc

Packages (3)

70436-161-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-02) 70436-161-04 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-04) 70436-161-06 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-06)

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": "44e07d95-cc64-cae9-e063-6294a90abc45", "openfda": {"upc": ["0370436160020", "0370436160068", "0370436161041", "0370436160044", "0370436161027", "0370436161065"], "unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["bbbee85a-e5e2-24ec-e053-2995a90acfd8"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-02)", "package_ndc": "70436-161-02", "marketing_start_date": "20210412"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-04)", "package_ndc": "70436-161-04", "marketing_start_date": "20210412"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-06)", "package_ndc": "70436-161-06", "marketing_start_date": "20210412"}], "brand_name": "Tolterodine Tartrate", "product_id": "70436-161_44e07d95-cc64-cae9-e063-6294a90abc45", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70436-161", "generic_name": "Tolterodine Tartrate", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine Tartrate", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "4 mg/1"}], "application_number": "ANDA213858", "marketing_category": "ANDA", "marketing_start_date": "20210412", "listing_expiration_date": "20261231"}