NDC 43975-323

Tolterodine Tartrate

Tolterodine Tartrate

Tolterodine Tartrate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ani Pharmaceuticals, Inc.. The primary component is Tolterodine Tartrate.

Product ID43975-323_1ca7b2c9-c06d-4f6e-a6f4-4709ab5c861f
NDC43975-323
Product TypeHuman Prescription Drug
Proprietary NameTolterodine Tartrate
Generic NameTolterodine Tartrate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA204562
Labeler NameANI Pharmaceuticals, Inc.
Substance NameTOLTERODINE TARTRATE
Active Ingredient Strength4 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 43975-323-03

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03)
Marketing Start Date2019-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43975-323-50 [43975032350]

Tolterodine Tartrate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204562
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-29

NDC 43975-323-09 [43975032309]

Tolterodine Tartrate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-29

NDC 43975-323-03 [43975032303]

Tolterodine Tartrate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-29

Drug Details

Active Ingredients

IngredientStrength
TOLTERODINE TARTRATE4 mg/1

OpenFDA Data

SPL SET ID:fc5bdc4a-a483-4d31-807b-c7f8d8869723
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855189
  • 855182
    • UPC Code
  • 0343975323096
  • 0343975322099

    • Pharmacological Class

    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "Tolterodine Tartrate" or generic name "Tolterodine Tartrate"

    NDCBrand NameGeneric Name
    0093-0010Tolterodine TartrateTolterodine Tartrate
    0093-0018Tolterodine TartrateTolterodine Tartrate
    0093-2049Tolterodine TartrateTolterodine Tartrate
    0093-2050Tolterodine TartrateTolterodine Tartrate
    0093-2055Tolterodine TartrateTolterodine Tartrate
    0093-2056Tolterodine TartrateTolterodine Tartrate
    0093-7163Tolterodine TartrateTolterodine Tartrate
    0093-7164Tolterodine TartrateTolterodine Tartrate
    0378-3402Tolterodine TartrateTolterodine Tartrate
    0378-3404Tolterodine TartrateTolterodine Tartrate
    0904-6592TOLTERODINE TARTRATETOLTERODINE
    0904-6593TOLTERODINE TARTRATETOLTERODINE
    10135-706TOLTERODINE TARTRATETOLTERODINE TARTRATE
    10135-707TOLTERODINE TARTRATETOLTERODINE TARTRATE
    13668-189TOLTERODINE TARTRATETOLTERODINE
    68151-3549Tolterodine TartrateTolterodine Tartrate
    68151-4247Tolterodine TartrateTolterodine Tartrate
    68151-4281Tolterodine TartrateTolterodine Tartrate
    70518-1416Tolterodine TartrateTolterodine Tartrate
    70518-1873Tolterodine TartrateTolterodine Tartrate
    71610-002Tolterodine TartrateTolterodine Tartrate
    13668-190TOLTERODINE TARTRATETOLTERODINE TARTRATE
    31722-608Tolterodine TartrateTolterodine Tartrate
    31722-607Tolterodine TartrateTolterodine Tartrate
    33342-098Tolterodine tartrateTolterodine tartrate
    33342-097Tolterodine tartrateTolterodine tartrate
    43353-346Tolterodine TartrateTolterodine Tartrate
    50090-3475Tolterodine TartrateTolterodine Tartrate
    51079-197Tolterodine TartrateTolterodine Tartrate
    51079-198Tolterodine TartrateTolterodine Tartrate
    59762-0800Tolterodine TartrateTolterodine Tartrate
    60429-825Tolterodine TartrateTolterodine Tartrate
    60429-826Tolterodine TartrateTolterodine Tartrate
    59762-0170Tolterodine TartrateTolterodine Tartrate
    60687-319Tolterodine TartrateTolterodine Tartrate
    60687-330Tolterodine TartrateTolterodine Tartrate
    71205-319Tolterodine TartrateTolterodine Tartrate
    43975-322Tolterodine TartrateTolterodine Tartrate
    43975-323Tolterodine TartrateTolterodine Tartrate
    0009-4541Detroltolterodine tartrate
    0009-4544Detroltolterodine tartrate
    0009-5190Detrol LAtolterodine tartrate
    0009-5191Detrol LAtolterodine tartrate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.