FDA.reportPublic FDA data

Sapropterin Dihydrochloride

Product NDC
59651-574
11-digit product format
596510574
Labeler code
59651
Product ID
59651-574_11ee25bc-f501-4f9d-b63d-63b2eee0147e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216797
Marketing category
ANDA
Marketing start
2025-06-09
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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216797-001SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216797-001AB

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 UTC2026-02A216797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-096a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216797-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216797-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216797-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216797-001AB1a50c72e98297…

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1486687Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11ee25bc-f501-4f9d-b63d-63b2eee0147eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211
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
59651-574-08Sapropterin Dihydrochloride120 in 1 BOTTLETABLET1201
59651-574-24Sapropterin Dihydrochloride240 in 1 BOTTLETABLET2401
59651-574-30Sapropterin Dihydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-574-08EA - Each59651-57478f5b62b-3a21-4535-9314-1ec6dbf5ed9f12025-08-11

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 DIHYDROCHLORIDEAurobindo Pharma Limited11ee25bc-f501-4f9d-b63d-63b2eee0147e2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216797
application number: ANDA216797
ndc (product): 59651-574

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486687sapropterin dihydrochloride 100 MG Oral TabletPSN11ee25bc-f501-4f9d-b63d-63b2eee0147e1
1486687sapropterin dihydrochloride 100 MG Oral TabletSCD11ee25bc-f501-4f9d-b63d-63b2eee0147e1
1486687sapropterin dihydrochloride 100 MG Soluble TabletSY11ee25bc-f501-4f9d-b63d-63b2eee0147e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-574-0859651057408120 TABLET in 1 BOTTLE (59651-574-08) 120 tablet2025-06-09NoNoCurrent
59651-574-2459651057424240 TABLET in 1 BOTTLE (59651-574-24) 240 tablet2025-06-09NoNoCurrent
59651-574-305965105743030 TABLET in 1 BOTTLE (59651-574-30) 30 tablet2025-06-09NoNoCurrent