tolterodine tartrate

Generic: tolterodine tartrate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tolterodine tartrate 4 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43975-323
Product ID 43975-323_361c4d47-0750-6f78-e063-6394a90ab0c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204562
Listing Expiration 2026-12-31
Marketing Start 2019-08-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43975323
Hyphenated Format 43975-323

Supplemental Identifiers

RxCUI
855182 855189
UPC
0343975323034 0343975322037
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 ANDA204562 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50)
source: ndc

Packages (3)

43975-323-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03) 43975-323-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09) 43975-323-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50)

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": "361c4d47-0750-6f78-e063-6394a90ab0c0", "openfda": {"upc": ["0343975323034", "0343975322037"], "unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["fc5bdc4a-a483-4d31-807b-c7f8d8869723"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03)", "package_ndc": "43975-323-03", "marketing_start_date": "20190829"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09)", "package_ndc": "43975-323-09", "marketing_start_date": "20190829"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50)", "package_ndc": "43975-323-50", "marketing_start_date": "20190829"}], "brand_name": "Tolterodine Tartrate", "product_id": "43975-323_361c4d47-0750-6f78-e063-6394a90ab0c0", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43975-323", "generic_name": "Tolterodine Tartrate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine Tartrate", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "4 mg/1"}], "application_number": "ANDA204562", "marketing_category": "ANDA", "marketing_start_date": "20190829", "listing_expiration_date": "20261231"}