FDA.reportPublic FDA data

Kuvan

Product NDC
68135-482
11-digit product format
681350482
Labeler code
68135
Product ID
68135-482_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
2015-05-27
Substance
SAPROPTERIN DIHYDROCHLORIDE
Active strength
500 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
IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1111018, 1111020, 1486687, 1486691, 1653217, 1653221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-482-10Kuvan1 in 1 PACKETPOWDER, FOR SOLUTION179
68135-482-11Kuvan30 in 1 CARTONPOWDER, FOR SOLUTION3079

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68135-482-10EA - Each68135-482337e7280-c1f0-4937-b55c-45ca7182779f12015-07-20
68135-482-11EA - Each68135-482c34bb708-2fdf-472e-ae38-e9a2bfec0b7b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SAPROPTERIN DIHYDROCHLORIDEACTIVE INGREDIENTRG277LF5B3KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
SAPROPTERINACTIVE MOIETYEGX657432IKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JKUVAN (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 INGREDIENT68401960MKKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
MANNITOLINACTIVE INGREDIENT3OWL53L36AKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
RIBOFLAVININACTIVE INGREDIENTTLM2976OFRKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIKUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]35
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4KUVAN (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
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-482KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.]78Current NDC, Legacy NDC, 2 package rows20240912_af38711e-8873-4790-a92d-4d583e23fb89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486691KUVAN 100 MG Oral TabletPSNaf38711e-8873-4790-a92d-4d583e23fb8979
1111020KUVAN 100 MG Powder for Oral SolutionPSNaf38711e-8873-4790-a92d-4d583e23fb8979
1653221KUVAN 500 MG Powder for Oral SolutionPSNaf38711e-8873-4790-a92d-4d583e23fb8979
1486687sapropterin dihydrochloride 100 MG Oral TabletPSNaf38711e-8873-4790-a92d-4d583e23fb8979
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionPSNaf38711e-8873-4790-a92d-4d583e23fb8979
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSNaf38711e-8873-4790-a92d-4d583e23fb8979
1486691sapropterin dihydrochloride 100 MG Oral Tablet [Kuvan]SBDaf38711e-8873-4790-a92d-4d583e23fb8979
1111020sapropterin dihydrochloride 100 MG Powder for Oral Solution [Kuvan]SBDaf38711e-8873-4790-a92d-4d583e23fb8979
1653221sapropterin dihydrochloride 500 MG Powder for Oral Solution [Kuvan]SBDaf38711e-8873-4790-a92d-4d583e23fb8979
1486687sapropterin dihydrochloride 100 MG Oral TabletSCDaf38711e-8873-4790-a92d-4d583e23fb8979
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionSCDaf38711e-8873-4790-a92d-4d583e23fb8979
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCDaf38711e-8873-4790-a92d-4d583e23fb8979
1486691Kuvan 100 MG Oral TabletSYaf38711e-8873-4790-a92d-4d583e23fb8979
1111020Kuvan 100 MG Powder for Oral SolutionSYaf38711e-8873-4790-a92d-4d583e23fb8979
1653221Kuvan 500 MG (sapropterin 384 MG) Powder for Oral SolutionSYaf38711e-8873-4790-a92d-4d583e23fb8979
1486687sapropterin dihydrochloride 100 MG Soluble TabletSYaf38711e-8873-4790-a92d-4d583e23fb8979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68135-482-10681350482101 in 1 PACKETHistorical
68135-482-116813504821130 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) 30 packet2015-05-270000-00-00NoNoCurrent