NDC 31722-048

Sapropterin dihydrochloride

Sapropterin Dihydrochloride

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

Product ID31722-048_eaab2cef-90ba-2002-e053-2a95a90a09fc
NDC31722-048
Product TypeHuman Prescription Drug
Proprietary NameSapropterin dihydrochloride
Generic NameSapropterin Dihydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2022-08-18
Marketing CategoryANDA /
Application NumberANDA215420
Labeler NameCamber Pharmaceuticals, 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 31722-048-30

30 PACKET in 1 CARTON (31722-048-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)
Marketing Start Date2022-08-18
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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