tolterodine tartrate

Generic: tolterodine tartrate

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolterodine tartrate
Generic Name tolterodine tartrate
Labeler ajanta pharma usa inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tolterodine tartrate 4 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-192
Product ID 27241-192_cf018a04-660f-4119-898f-1877a5db8e7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213397
Listing Expiration 2027-12-31
Marketing Start 2020-06-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241192
Hyphenated Format 27241-192

Supplemental Identifiers

RxCUI
855182 855189
UPC
0327241192302 0327241191305
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 ANDA213397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-90)
source: ndc

Packages (3)

27241-192-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05) 27241-192-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-30) 27241-192-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-90)

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": "cf018a04-660f-4119-898f-1877a5db8e7e", "openfda": {"upc": ["0327241192302", "0327241191305"], "unii": ["5T619TQR3R"], "rxcui": ["855182", "855189"], "spl_set_id": ["fcaca033-cd08-4b8c-9bad-7b6751faf2c9"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05)", "package_ndc": "27241-192-05", "marketing_start_date": "20200625"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-30)", "package_ndc": "27241-192-30", "marketing_start_date": "20200625"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-90)", "package_ndc": "27241-192-90", "marketing_start_date": "20200625"}], "brand_name": "Tolterodine tartrate", "product_id": "27241-192_cf018a04-660f-4119-898f-1877a5db8e7e", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "27241-192", "generic_name": "Tolterodine tartrate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolterodine tartrate", "active_ingredients": [{"name": "TOLTERODINE TARTRATE", "strength": "4 mg/1"}], "application_number": "ANDA213397", "marketing_category": "ANDA", "marketing_start_date": "20200625", "listing_expiration_date": "20271231"}