NDC 43598-477

Sapropterin Dihydrochloride

Sapropterin Dihydrochloride

Sapropterin Dihydrochloride is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddys Laboratories Inc. The primary component is Sapropterin Dihydrochloride.

Product ID43598-477_de177a71-0a19-b267-0676-34415c9d5fea
NDC43598-477
Product TypeHuman Prescription Drug
Proprietary NameSapropterin Dihydrochloride
Generic NameSapropterin Dihydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2021-04-01
Marketing CategoryANDA /
Application NumberANDA209452
Labeler NameDr. Reddys Laboratories Inc
Substance NameSAPROPTERIN DIHYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesPhenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 43598-477-30

30 PACKET in 1 CARTON (43598-477-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (43598-477-11)
Marketing Start Date2021-04-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Sapropterin Dihydrochloride" or generic name "Sapropterin Dihydrochloride"

NDCBrand NameGeneric Name
43598-477Sapropterin DihydrochlorideSapropterin Dihydrochloride
43598-749Sapropterin DihydrochlorideSapropterin Dihydrochloride
49884-720sapropterin dihydrochloridesapropterin dihydrochloride
49884-873SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
49884-948SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDE
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDE
68135-482Kuvansapropterin dihydrochloride

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