NDC 52605-067

Darifenacin

Darifenacin Hydrobromide

Darifenacin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Polygen Pharmaceuticals Inc.. The primary component is Darifenacin Hydrobromide.

Product ID52605-067_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4
NDC52605-067
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA211045
Labeler NamePOLYGEN PHARMACEUTICALS INC.
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 52605-067-10

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-10)
Marketing Start Date2020-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Darifenacin" or generic name "Darifenacin Hydrobromide"

NDCBrand NameGeneric Name
0591-4375Darifenacindarifenacin
0591-4380Darifenacindarifenacin
13668-202DarifenacinDarifenacin
13668-203DarifenacinDarifenacin
16571-767DarifenacinDarifenacin
16571-768DarifenacinDarifenacin
33342-276DarifenacinDarifenacin
33342-277DarifenacinDarifenacin
46708-223DARIFENACINDARIFENACIN
46708-224DARIFENACINDARIFENACIN
52605-067DarifenacinDarifenacin Hydrobromide
69097-432DarifenacinDarifenacin
69097-431DarifenacinDarifenacin
59746-517darifenacindarifenacin
59746-516darifenacindarifenacin
62332-224DARIFENACINDARIFENACIN
62332-223DARIFENACINDARIFENACIN
65862-862DarifenacinDarifenacin
65862-861DarifenacinDarifenacin
52605-068DarifenacinDarifenacin
10370-170Darifenacin HydrobromideDarifenacin Hydrobromide
10370-171Darifenacin HydrobromideDarifenacin Hydrobromide
42291-206Darifenacin HydrobromideDarifenacin Hydrobromide
42291-207Darifenacin HydrobromideDarifenacin Hydrobromide
0430-0170Enablexdarifenacin
0430-0171Enablexdarifenacin
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.