NDC 70700-182

Darifenacin 7.5 mg

Darifenacin Hydrobromide

Darifenacin 7.5 mg is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Xiromed, Llc. The primary component is Darifenacin Hydrobromide.

Product ID70700-182_045ab360-9ad8-5d11-f670-a97c2604cb1c
NDC70700-182
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin 7.5 mg
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-04-30
Marketing CategoryANDA /
Application NumberANDA209571
Labeler NameXiromed, LLC
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70700-182-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70700-182-30)
Marketing Start Date2021-04-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Darifenacin 7.5 mg" or generic name "Darifenacin Hydrobromide"

NDCBrand NameGeneric Name
70700-182Darifenacin 7.5 mgDarifenacin Hydrobromide
52605-067DarifenacinDarifenacin Hydrobromide
52605-068DarifenacinDarifenacin Hydrobromide
59746-516darifenacindarifenacin hydrobromide
59746-517darifenacindarifenacin hydrobromide
69097-431DarifenacinDarifenacin Hydrobromide
69097-432DarifenacinDarifenacin Hydrobromide
70700-183Darifenacin 15 mgDarifenacin Hydrobromide
10370-170Darifenacin HydrobromideDarifenacin Hydrobromide
10370-171Darifenacin HydrobromideDarifenacin Hydrobromide
42291-206Darifenacin HydrobromideDarifenacin Hydrobromide
42291-207Darifenacin HydrobromideDarifenacin Hydrobromide
60429-850Darifenacin HydrobromideDarifenacin Hydrobromide
60429-851Darifenacin HydrobromideDarifenacin Hydrobromide

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.