NDC 43598-162

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 ID43598-162_572d3515-61be-a260-120e-74357c80fe5f
NDC43598-162
Product TypeHuman Prescription Drug
Proprietary NameSapropterin Dihydrochloride
Generic NameSapropterin Dihydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2022-11-16
Marketing CategoryANDA /
Application NumberANDA215798
Labeler NameDr. Reddys Laboratories Inc
Substance NameSAPROPTERIN DIHYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBreast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 43598-162-30

30 PACKET in 1 CARTON (43598-162-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (43598-162-11)
Marketing Start Date2022-11-16
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
31722-045sapropterin dihydrochloridesapropterin dihydrochloride
31722-047Sapropterin dihydrochlorideSapropterin dihydrochloride
31722-048Sapropterin dihydrochlorideSapropterin dihydrochloride
43598-162Sapropterin DihydrochlorideSapropterin Dihydrochloride
43598-477Sapropterin DihydrochlorideSapropterin Dihydrochloride
43598-749Sapropterin DihydrochlorideSapropterin Dihydrochloride
49884-720sapropterin dihydrochloridesapropterin dihydrochloride
49884-873SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
49884-948SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
43598-096JAVYGTORSapropterin Dihydrochloride
43598-097JAVYGTORSapropterin Dihydrochloride
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDE
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDE
68135-482Kuvansapropterin dihydrochloride

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