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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216432-001SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE100MG/PACKETFOR SOLUTION / ORALAB2025-09-03
A216432-002SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE500MG/PACKETFOR SOLUTION / ORALAB2025-09-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216432-001AB
A216432-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216432-001SAPROPTERIN DIHYDROCHLORIDE100MG/PACKETPOWDER / ORALAB2025-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216432-002SAPROPTERIN DIHYDROCHLORIDE500MG/PACKETPOWDER / ORALAB2025-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216432-001SAPROPTERIN DIHYDROCHLORIDE100MG/PACKETPOWDER / ORALAB2025-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216432-002SAPROPTERIN DIHYDROCHLORIDE500MG/PACKETPOWDER / ORALAB2025-09-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216432-001SAPROPTERIN DIHYDROCHLORIDE100MG/PACKETFOR SOLUTION / ORALAB2025-09-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216432-002SAPROPTERIN DIHYDROCHLORIDE500MG/PACKETFOR SOLUTION / ORALAB2025-09-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216432-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216432-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216432-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216432-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216432-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216432-002AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RG277LF5B3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111018Internal RxNorm lookup
1653217Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39f1d020-4359-401b-88a8-ed25eaa40b45Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDETRUPHARMA, LLC39f1d020-4359-401b-88a8-ed25eaa40b452026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216432
application number: ANDA216432
ndc (product): 52817-851

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) 2026-01-30NoNoCurrent
52817-851-305281708513030 POWDER, FOR SOLUTION in 1 CARTON (52817-851-30) 2026-01-30NoNoCurrent