tolterodine tartrate

Generic: tolterodine

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

Drug Facts

Product Profile

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

tolterodine tartrate 2 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-189
Product ID 13668-189_de456fdd-b0a2-4b65-b926-bb9948fde276
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203016
Listing Expiration 2027-12-31
Marketing Start 2015-08-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668189
Hyphenated Format 13668-189

Supplemental Identifiers

RxCUI
855182 855189
UPC
0313668189308 0313668190304
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 (source: ndc)
Application Number ANDA203016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30)
  • 100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-90)
source: ndc

Packages (4)

13668-189-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05) 13668-189-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30) 13668-189-74 100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74) 13668-189-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-90)

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": "de456fdd-b0a2-4b65-b926-bb9948fde276", "openfda": {"upc": ["0313668189308", "0313668190304"], "unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["db6e0b6d-0ce5-41d7-881f-881c11f530a4"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05)", "package_ndc": "13668-189-05", "marketing_start_date": "20150811"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30)", "package_ndc": "13668-189-30", "marketing_start_date": "20150811"}, {"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74)", "package_ndc": "13668-189-74", "marketing_start_date": "20150811"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-90)", "package_ndc": "13668-189-90", "marketing_start_date": "20150811"}], "brand_name": "TOLTERODINE TARTRATE", "product_id": "13668-189_de456fdd-b0a2-4b65-b926-bb9948fde276", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "13668-189", "generic_name": "TOLTERODINE", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLTERODINE TARTRATE", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "2 mg/1"}], "application_number": "ANDA203016", "marketing_category": "ANDA", "marketing_start_date": "20150811", "listing_expiration_date": "20271231"}