Sapropterin Dihydrochloride — ingredient monograph

Overview

Source: NDC Directory

Ingredient name

SAPROPTERIN DIHYDROCHLORIDE

Base moiety

SAPROPTERIN DIHYDROCHLORIDE

RxNorm CUI

1486687

UNII

RG277LF5B3

Medication products

9

Brand names

5

Dosage forms

3

FAERS reports

6,334 · not a risk measure

Products containing this ingredient

Source: NDC Directory 9 products

JAVYGTOR Sapropterin Dihydrochloride · Tablet
Rx ANDA TE AB 1 recall 1 NDC
Kuvan Sapropterin Dihydrochloride · Tablet
Rx NDA TE AB 1 NDC
Sapropterin Dihydrochloride Powder
9 NDC
Sapropterine Dihydrochloride Powder
1 NDC
JAVYGTOR Sapropterin Dihydrochloride · Powder, for Solution
Rx ANDA TE AB 1 recall 2 NDC
Kuvan sapropterin dihydrochloride · Powder, for Solution
Rx NDA TE AB 2 NDC
sapropterin dihydrochloride Tablet
Rx ANDA TE AB 6 NDC
Sapropterin Dihydrochloride Powder, for Solution
Rx ANDA TE AB 10 NDC
ZELVYSIA Sapropterin Dihydrochloride · Powder, for Solution
Rx ANDA TE AB 2 NDC

Entries without a link are products listed by the FDA that carry no approval record, therapeutic equivalence rating or official labelling, so they have no detail page. Their facts are shown inline.

By dosage form

How this ingredient is presented across the catalogue.
Dosage form	Products	Examples
POWDER, For Solution	4	JAVYGTOR, Kuvan, Sapropterin Dihydrochloride, ZELVYSIA
Tablet	3	JAVYGTOR, Kuvan, sapropterin dihydrochloride
Powder	2	Sapropterin Dihydrochloride, Sapropterine Dihydrochloride

Sources for this page

Dataset	Agency	Used for
NDC Directory	FDA	Ingredient name, strengths, products, labelers, packages
DailyMed RxNorm mappings	NLM	RxNorm concept identifier (RxCUI)
FAERS	FDA	Adverse event report totals