FDA.reportPublic FDA data

Sapropterin dihydrochloride

Product NDC
31722-047
11-digit product format
317220047
Labeler code
31722
Product ID
31722-047_4c45ff1f-15f2-2237-e063-6294a90a0aca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin dihydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215420
Marketing category
ANDA
Marketing start
2022-08-18
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
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 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
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
31722-047-01Sapropterin dihydrochloride1 in 1 PACKETPOWDER, FOR SOLUTION13
31722-047-30Sapropterin dihydrochloride30 in 1 CARTONPOWDER, FOR SOLUTION303
31722-047-31Sapropterin dihydrochloride1 in 1 CARTONPOWDER, FOR SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-047-01EA - Each31722-0476d999e39-c76a-4e90-a95f-2b63fee7baf512023-02-06
31722-047-30EA - Each31722-047678de7e0-b1a3-4e6c-834f-d0a8baadefce12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-047SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20240710_3f0d6820-ff59-40c0-882f-aeea2dd1d1ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionPSN3f0d6820-ff59-40c0-882f-aeea2dd1d1ad3
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSN3f0d6820-ff59-40c0-882f-aeea2dd1d1ad3
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionSCD3f0d6820-ff59-40c0-882f-aeea2dd1d1ad3
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCD3f0d6820-ff59-40c0-882f-aeea2dd1d1ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-047-01317220047011 in 1 PACKETHistorical
31722-047-303172200473030 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) 30 packet2022-08-180000-00-00NoNoCurrent
31722-047-31317220047311 PACKET in 1 CARTON (31722-047-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) 1 packet2022-08-180000-00-00NoNoCurrent