NDC 60687-449

Sevelamer Hydrochloride

Sevelamer Hydrochloride

Sevelamer Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Sevelamer Hydrochloride.

Product ID60687-449_95ab3a33-9957-5043-e053-2a95a90a67e0
NDC60687-449
Product TypeHuman Prescription Drug
Proprietary NameSevelamer Hydrochloride
Generic NameSevelamer Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA204724
Labeler NameAmerican Health Packaging
Substance NameSEVELAMER HYDROCHLORIDE
Active Ingredient Strength800 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60687-449-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)
Marketing Start Date2019-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-449-01 [60687044901]

Sevelamer Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204724
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-01

NDC 60687-449-11 [60687044911]

Sevelamer Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204724
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-01

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER HYDROCHLORIDE800 mg/1

Pharmacological Class

  • Phosphate Binder [EPC]
  • Phosphate Chelating Activity [MoA]
  • Phosphate Binder [EPC]
  • Phosphate Chelating Activity [MoA]

NDC Crossover Matching brand name "Sevelamer Hydrochloride" or generic name "Sevelamer Hydrochloride"

NDCBrand NameGeneric Name
0955-1048Sevelamer HydrochlorideSevelamer Hydrochloride
60687-449Sevelamer HydrochlorideSevelamer Hydrochloride
68462-446sevelamer hydrochloridesevelamer hydrochloride
68462-447sevelamer hydrochloridesevelamer hydrochloride
70748-172Sevelamer hydrochlorideSevelamer hydrochloride
70748-173Sevelamer hydrochlorideSevelamer hydrochloride
58468-0021Renagelsevelamer hydrochloride

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