FDA.reportPublic FDA data

sapropterin dihydrochloride

Product NDC
0054-0906
11-digit product format
000540906
Labeler code
0054
Product ID
0054-0906_d61800d3-94cc-46ce-8687-b467c63ac9fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sapropterin dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA218797
Marketing category
ANDA
Marketing start
2025-10-23
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
A218797-001SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218797-001AB

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 UTC2026-02A218797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218797-001SAPROPTERIN DIHYDROCHLORIDE100MGTABLET / ORALAB2025-06-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218797-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218797-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218797-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218797-001AB1a50c72e98297…

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
c4d92cce-e899-4f14-b19c-5e17f9922215Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0906-23sapropterin dihydrochloride120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0906-23EA - Each0054-09063cf96daf-c58c-4c8b-b478-fbc2725c7e1912025-11-13

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 DIHYDROCHLORIDEHikma Pharmaceuticals USA Inc.c4d92cce-e899-4f14-b19c-5e17f99222152025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218797
application number: ANDA218797
ndc (product): 0054-0906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486687sapropterin dihydrochloride 100 MG Oral TabletPSNc4d92cce-e899-4f14-b19c-5e17f99222152
1486687sapropterin dihydrochloride 100 MG Oral TabletSCDc4d92cce-e899-4f14-b19c-5e17f99222152
1486687sapropterin dihydrochloride 100 MG Soluble TabletSYc4d92cce-e899-4f14-b19c-5e17f99222152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0906-2300054090623120 TABLET in 1 BOTTLE (0054-0906-23) 120 tablet2025-10-23NoNoCurrent