tolterodine tartrate

Generic: tolterodine tartrate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolterodine tartrate
Generic Name tolterodine tartrate
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tolterodine tartrate 2 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-127
Product ID 16571-127_d56e7ced-4633-4325-8e3d-166c84c05886
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204721
Listing Expiration 2026-12-31
Marketing Start 2020-01-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571127
Hyphenated Format 16571-127

Supplemental Identifiers

RxCUI
855178 855194
UPC
0316571126064 0316571127061
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 ANDA204721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-127-01)
  • 60 TABLET, FILM COATED in 1 BOTTLE (16571-127-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50)
source: ndc

Packages (3)

16571-127-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-127-01) 16571-127-06 60 TABLET, FILM COATED in 1 BOTTLE (16571-127-06) 16571-127-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50)

Ingredients (1)

tolterodine tartrate (2 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": "d56e7ced-4633-4325-8e3d-166c84c05886", "openfda": {"upc": ["0316571126064", "0316571127061"], "unii": ["5T619TQR3R"], "rxcui": ["855178", "855194"], "spl_set_id": ["b9ba8ad2-27f6-4f18-bd84-73659047910e"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-127-01)", "package_ndc": "16571-127-01", "marketing_start_date": "20200124"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (16571-127-06)", "package_ndc": "16571-127-06", "marketing_start_date": "20200124"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50)", "package_ndc": "16571-127-50", "marketing_start_date": "20200124"}], "brand_name": "Tolterodine Tartrate", "product_id": "16571-127_d56e7ced-4633-4325-8e3d-166c84c05886", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16571-127", "generic_name": "Tolterodine Tartrate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine Tartrate", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "2 mg/1"}], "application_number": "ANDA204721", "marketing_category": "ANDA", "marketing_start_date": "20200124", "listing_expiration_date": "20261231"}