tolterodine tartrate

Generic: tolterodine tartrate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolterodine tartrate
Generic Name tolterodine tartrate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tolterodine tartrate 2 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-306
Product ID 29300-306_1d40a6e0-df38-4fd8-bfea-5d19c9d071ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216917
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300306
Hyphenated Format 29300-306

Supplemental Identifiers

RxCUI
855182 855189
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 ANDA216917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-13)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-19)
source: ndc

Packages (3)

29300-306-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-05) 29300-306-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-13) 29300-306-19 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-19)

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": "1d40a6e0-df38-4fd8-bfea-5d19c9d071ab", "openfda": {"unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["9710ad7b-93c2-4ec1-95ff-597563be4314"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-05)", "package_ndc": "29300-306-05", "marketing_start_date": "20241001"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-13)", "package_ndc": "29300-306-13", "marketing_start_date": "20241001"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-19)", "package_ndc": "29300-306-19", "marketing_start_date": "20241001"}], "brand_name": "Tolterodine tartrate", "product_id": "29300-306_1d40a6e0-df38-4fd8-bfea-5d19c9d071ab", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "29300-306", "generic_name": "Tolterodine tartrate", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine tartrate", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "2 mg/1"}], "application_number": "ANDA216917", "marketing_category": "ANDA", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}