FDA.reportPublic FDA data

Sapropterin dihydrochloride

Product NDC
72603-193
11-digit product format
726030193
Labeler code
72603
Product ID
72603-193_1ccf4222-e182-b467-e063-6394a90a76ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin dihydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA215420
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
Rxcui1111018, 1653217

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-193-01Sapropterin dihydrochloride1 in 1 PACKETPOWDER, FOR SOLUTION13
72603-193-30Sapropterin dihydrochloride30 in 1 CARTONPOWDER, FOR SOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-193-01EA - Each72603-1930a570cf8-98d4-4f00-ba40-6405307ab01412024-07-12
72603-193-30EA - Each72603-19365108001-cbfe-4850-917b-186fa6156ec612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-193SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [NORTHSTAR RXLLC]3Current NDC, 2 package rows20240710_b3999f74-920d-4444-afa7-f4211e4eb431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionPSNb3999f74-920d-4444-afa7-f4211e4eb4313
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSNb3999f74-920d-4444-afa7-f4211e4eb4313
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionSCDb3999f74-920d-4444-afa7-f4211e4eb4313
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCDb3999f74-920d-4444-afa7-f4211e4eb4313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-193-01726030193011 in 1 PACKETHistorical
72603-193-307260301933030 PACKET in 1 CARTON (72603-193-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (72603-193-01) 30 packet2023-12-01NoNoHistorical