FDA.reportPublic FDA data

sapropterin dihydrochloride

Product NDC
72603-191
11-digit product format
726030191
Labeler code
72603
Product ID
72603-191_2b08d642-3262-b372-e063-6294a90afc2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sapropterin dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA215534
Marketing category
ANDA
Marketing start
2023-12-01
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-191-01sapropterin dihydrochloride120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-191-01EA - Each72603-19196a56d17-3812-4430-a975-bf3a5a47d80712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-191SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) TABLET [NORTHSTAR RXLLC]3Current NDC, 1 package rows20250108_a64a50ba-e3da-4227-9bce-87101d60409e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486687sapropterin dihydrochloride 100 MG Oral TabletPSNa64a50ba-e3da-4227-9bce-87101d60409e3
1486687sapropterin dihydrochloride 100 MG Oral TabletSCDa64a50ba-e3da-4227-9bce-87101d60409e3
1486687sapropterin dihydrochloride 100 MG Soluble TabletSYa64a50ba-e3da-4227-9bce-87101d60409e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-191-0172603019101120 TABLET in 1 BOTTLE (72603-191-01) 120 tablet2023-12-01NoNoHistorical