FDA.reportPublic FDA data

Sapropterin Dihydrochloride

Product NDC
52817-851
11-digit product format
528170851
Labeler code
52817
Product ID
52817-851_4b1fe6f7-f641-ec9a-e063-6394a90a4e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin Dihydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
TRUPHARMA, LLC
Application
ANDA216432
Marketing category
ANDA
Marketing start
2026-01-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sapropterin Dihydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1111018, 1653217

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
52817-851-01Sapropterin Dihydrochloride1 in 1 POUCHPOWDER, FOR SOLUTION12
52817-851-30Sapropterin Dihydrochloride30 in 1 CARTONPOWDER, FOR SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-851-01EA - Each52817-8513d694efc-6c31-4f87-a13a-a672cdd181d312026-01-08
52817-851-30EA - Each52817-851f39d1e1b-4675-4935-b9d2-05b40741c9b012026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionPSN39f1d020-4359-401b-88a8-ed25eaa40b452
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSN39f1d020-4359-401b-88a8-ed25eaa40b452
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionSCD39f1d020-4359-401b-88a8-ed25eaa40b452
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCD39f1d020-4359-401b-88a8-ed25eaa40b452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52817-851-01528170851011 POWDER, FOR SOLUTION in 1 POUCH (52817-851-01) 2026-01-30NoNoHistorical
52817-851-305281708513030 POWDER, FOR SOLUTION in 1 CARTON (52817-851-30) 2026-01-30NoNoHistorical