NDC 59651-095

SILODOSIN

Silodosin

SILODOSIN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Silodosin.

Product ID59651-095_2989e3b0-78d5-4ca7-8000-9a645e7eb1f4
NDC59651-095
Product TypeHuman Prescription Drug
Proprietary NameSILODOSIN
Generic NameSilodosin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA210626
Labeler NameAurobindo Pharma Limited
Substance NameSILODOSIN
Active Ingredient Strength4 mg/1
Pharm ClassesAdrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 59651-095-30

30 CAPSULE in 1 BOTTLE (59651-095-30)
Marketing Start Date2018-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59651-095-90 [59651009590]

SILODOSIN CAPSULE
Marketing CategoryANDA
Application NumberANDA210626
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-10

NDC 59651-095-30 [59651009530]

SILODOSIN CAPSULE
Marketing CategoryANDA
Application NumberANDA210626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-10

Drug Details

Active Ingredients

IngredientStrength
SILODOSIN4 mg/1

OpenFDA Data

SPL SET ID:5e5038ea-9214-469b-8174-e5787be7a801
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 826612
  • 809477
  • Pharmacological Class

    • Adrenergic alpha-Antagonists [MoA]
    • alpha-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "SILODOSIN" or generic name "Silodosin"

    NDCBrand NameGeneric Name
    0781-2623SilodosinSilodosin
    0781-2624SilodosinSilodosin
    27241-144SilodosinSilodosin
    27241-145SilodosinSilodosin
    31722-635SilodosinSilodosin
    31722-636SilodosinSilodosin
    33342-384SilodosinSilodosin
    33342-385SilodosinSilodosin
    42291-777SilodosinSilodosin
    42291-778SilodosinSilodosin
    46708-405SilodosinSilodosin
    46708-406SilodosinSilodosin
    59651-095SILODOSINSILODOSIN
    59651-096SILODOSINSILODOSIN
    68180-740SilodosinSilodosin
    68180-741SilodosinSilodosin
    69238-1421SilodosinSilodosin
    69238-1420SilodosinSilodosin
    69539-052SILODOSINSILODOSIN
    69539-053SILODOSINSILODOSIN
    72205-010SILODOSINSILODOSIN
    72205-009SILODOSINSILODOSIN
    62332-406SilodosinSilodosin
    62332-405SilodosinSilodosin
    72789-090SILODOSINSILODOSIN
    0023-6142RAPAFLOsilodosin
    0023-6147RAPAFLOsilodosin
    52544-151RAPAFLOsilodosin
    52544-152RAPAFLOsilodosin

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