NDC 67877-528

Solifenacin Succinate

Solifenacin Succinate

Solifenacin Succinate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Solifenacin Succinate.

Product ID67877-528_7ab62d7b-23ff-4f1a-b90a-c4730437a6d9
NDC67877-528
Product TypeHuman Prescription Drug
Proprietary NameSolifenacin Succinate
Generic NameSolifenacin Succinate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA210224
Labeler NameAscend Laboratories, LLC
Substance NameSOLIFENACIN SUCCINATE
Active Ingredient Strength10 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 67877-528-30

30 TABLET, FILM COATED in 1 BOTTLE (67877-528-30)
Marketing Start Date2019-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-528-38 [67877052838]

Solifenacin Succinate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210224
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-21

NDC 67877-528-33 [67877052833]

Solifenacin Succinate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210224
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-21

NDC 67877-528-30 [67877052830]

Solifenacin Succinate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210224
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-21

NDC 67877-528-90 [67877052890]

Solifenacin Succinate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210224
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-21

Drug Details

Active Ingredients

IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

OpenFDA Data

SPL SET ID:97d8a21e-4618-460f-8cf5-97a9d946039e
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "Solifenacin Succinate" or generic name "Solifenacin Succinate"

NDCBrand NameGeneric Name
0093-5263Solifenacin SuccinateSolifenacin Succinate
0093-5264Solifenacin SuccinateSolifenacin Succinate
0591-3795Solifenacin succinatesolifenacin succinate
0591-3796Solifenacin succinatesolifenacin succinate
27241-037solifenacin succinatesolifenacin succinate
27241-038solifenacin succinatesolifenacin succinate
29300-328Solifenacin SuccinateSolifenacin Succinate
29300-329Solifenacin SuccinateSolifenacin Succinate
31722-027solifenacin succinatesolifenacin succinate
31722-028solifenacin succinatesolifenacin succinate
35561-285Solifenacin Succinatesolifenacin succiate
35561-286Solifenacin Succinatesolifenacin succinate
42291-739Solifenacin Succinatesolifenacin succiate
42291-740Solifenacin Succinatesolifenacin succinate
69539-051Solifenacin SuccinateSolifenacin Succinate
69539-050Solifenacin SuccinateSolifenacin Succinate
72205-020Solifenacin SuccinateSolifenacin Succinate
72606-010solifenacin succinatesolifenacin succinate
72606-009solifenacin succinatesolifenacin succinate
72205-021Solifenacin SuccinateSolifenacin Succinate
46708-193Solifenacin SuccinateSolifenacin Succinate
46708-192Solifenacin SuccinateSolifenacin Succinate
50228-427SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
50228-428SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
51407-227Solifenacin SuccinateSolifenacin Succinate
51407-228Solifenacin SuccinateSolifenacin Succinate
51991-893Solifenacin SuccinateSolifenacin Succinate
51991-894Solifenacin SuccinateSolifenacin Succinate
60505-4703Solifenacin SuccinateSolifenacin Succinate
60505-4702Solifenacin SuccinateSolifenacin Succinate
62332-192Solifenacin SuccinateSolifenacin Succinate
62332-193Solifenacin SuccinateSolifenacin Succinate
67877-527Solifenacin SuccinateSolifenacin Succinate
67877-528Solifenacin SuccinateSolifenacin Succinate
68462-387solifenacin succinatesolifenacin succinate
68462-386solifenacin succinatesolifenacin succinate
69238-1309Solifenacin SuccinateSolifenacin Succinate
69238-1308Solifenacin SuccinateSolifenacin Succinate
51407-254SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
51407-255SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
60687-499Solifenacin SuccinateSolifenacin Succinate
69367-239Solifenacin SuccinateSolifenacin Succinate
69367-240Solifenacin SuccinateSolifenacin Succinate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.