FDA.reportPublic FDA data

Sapropterin Dihydrochloride

Product NDC
59651-574
11-digit product format
596510574
Labeler code
59651
Product ID
59651-574_11ee25bc-f501-4f9d-b63d-63b2eee0147e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216797
Marketing category
ANDA
Marketing start
2025-06-09
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
Sapropterin Dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1486687

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-574-08Sapropterin Dihydrochloride120 in 1 BOTTLETABLET1201
59651-574-24Sapropterin Dihydrochloride240 in 1 BOTTLETABLET2401
59651-574-30Sapropterin Dihydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-574-08EA - Each59651-57478f5b62b-3a21-4535-9314-1ec6dbf5ed9f12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486687sapropterin dihydrochloride 100 MG Oral TabletPSN11ee25bc-f501-4f9d-b63d-63b2eee0147e1
1486687sapropterin dihydrochloride 100 MG Oral TabletSCD11ee25bc-f501-4f9d-b63d-63b2eee0147e1
1486687sapropterin dihydrochloride 100 MG Soluble TabletSY11ee25bc-f501-4f9d-b63d-63b2eee0147e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-574-0859651057408120 TABLET in 1 BOTTLE (59651-574-08) 120 tablet2025-06-09NoNoHistorical
59651-574-2459651057424240 TABLET in 1 BOTTLE (59651-574-24) 240 tablet2025-06-09NoNoHistorical
59651-574-305965105743030 TABLET in 1 BOTTLE (59651-574-30) 30 tablet2025-06-09NoNoHistorical