FDA.reportPublic FDA data

NDC 68135-301-11 - Kuvan

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68135-301
Requested NDC
68135-301-11
Package NDCs from labels
68135-301-11, 68135-301-22
Manufacturer
BioMarin Pharmaceutical Inc. | Almac Pharma Services Limited
Effective date
2024-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Kuvan - BioMarin Pharmaceutical Inc. | Almac Pharma Services LimitedBioMarin Pharmaceutical Inc. | Almac Pharma Services Limited2024-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-301-11Kuvan1 in 1 PACKETPOWDER, FOR SOLUTION179
68135-301-22Kuvan30 in 1 CARTONPOWDER, FOR SOLUTION3079

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-301KUVAN (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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDEHikma Pharmaceuticals USA Inc.c4d92cce-e899-4f14-b19c-5e17f99222152026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 1486687
unii: RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLC2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 1653217
unii: RG277LF5B3
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLCeafec3a2-4f29-4afa-8728-a62b34cefd182026-04-17Warnings, Adverse reactionsExact identifier
rxcui: 1486687
unii: RG277LF5B3
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.3f0d6820-ff59-40c0-882f-aeea2dd1d1ad2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.ec8ea96c-8ec1-4301-a85d-d59562e548ca2026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 1486687
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDETRUPHARMA, LLC39f1d020-4359-401b-88a8-ed25eaa40b452026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEMicro Labs Limited907e24c4-3337-4aee-b789-276e37a85cd82026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEAurobindo Pharma Limited11ee25bc-f501-4f9d-b63d-63b2eee0147e2025-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1486687
unii: RG277LF5B3
ZELVYSIASAPROPTERIN DIHYDROCHLORIDEAucta Pharmaceuticals, Inc.8de84882-dd24-46f2-8416-5e492d4275d12025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCa64a50ba-e3da-4227-9bce-87101d60409e2025-01-06Warnings, Adverse reactionsExact identifier
rxcui: 1486687
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inceecdd8c7-5f8a-0af1-793a-db2e2ba0f4912024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 1653217
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Incd9f3723f-bf7d-9a72-2ef9-41c5508d6ab42024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1486687
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inc1590afa1-baa4-70e5-5a3b-468401c710442024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1111018
unii: RG277LF5B3
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
application number: NDA022181
application number: NDA205065
ndc (package): 68135-482-10
ndc (package): 68135-300-02
ndc (package): 68135-301-22
ndc (package): 68135-301-11
ndc (package): 68135-482-11
ndc (product): 68135-301
ndc (product): 68135-482
ndc (product): 68135-300
ndc11 (package): 68135030111
rxcui: 1486687
rxcui: 1111020
rxcui: 1653221
rxcui: 1653217
rxcui: 1486691
rxcui: 1111018
spl id: c4286a54-6e01-4444-94a0-943411790e1d
spl set id: af38711e-8873-4790-a92d-4d583e23fb89
unii: RG277LF5B3
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCb3999f74-920d-4444-afa7-f4211e4eb4312024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLC6b2172e4-42fc-42fe-b1ad-9d6a974d43432020-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1111018
unii: RG277LF5B3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.