Home NDC 68135-301 Kuvan
Product NDC 68135-301
11-digit product format 681350301
Labeler code 68135
Product ID 68135-301_c4286a54-6e01-4444-94a0-943411790e1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SAPROPTERIN DIHYDROCHLORIDE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler BioMarin Pharmaceutical Inc.
Application NDA205065
Marketing category NDA
Marketing start 2014-02-21
Substance SAPROPTERIN DIHYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Kuvan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii RG277LF5B3 Rxcui 1111018, 1111020, 1486687, 1486691, 1653217, 1653221
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68135-301-11 Kuvan 1 in 1 PACKET POWDER, FOR SOLUTION 1 79 68135-301-22 Kuvan 30 in 1 CARTON POWDER, FOR SOLUTION 30 79
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SAPROPTERIN DIHYDROCHLORIDE ACTIVE INGREDIENT RG277LF5B3 KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 SAPROPTERIN ACTIVE MOIETY EGX657432I KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 MANNITOL INACTIVE INGREDIENT 3OWL53L36A KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 RIBOFLAVIN INACTIVE INGREDIENT TLM2976OFR KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68135-301 KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] 78 Current NDC, Legacy NDC, 2 package rows 20240912_af38711e-8873-4790-a92d-4d583e23fb89.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68135-301-11 68135030111 1 in 1 PACKET Historical 68135-301-22 68135030122 30 PACKET in 1 CARTON (68135-301-22) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11) 30 packet 2014-02-21 0000-00-00 No No Current