FDA.reportPublic FDA data

JAVYGTOR

Product NDC
43598-097
11-digit product format
435980097
Labeler code
43598
Product ID
43598-097_f6a11439-21eb-fc03-1869-6960d7cf8791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin Dihydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA209452
Marketing category
ANDA
Marketing start
2022-09-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
JAVYGTOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1111018, 2611951

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
43598-097-11JAVYGTOR1 in 1 PACKETPOWDER, FOR SOLUTION14
43598-097-30JAVYGTOR30 in 1 CARTONPOWDER, FOR SOLUTION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-097-11EA - Each43598-097085df6fe-245a-49ca-aad7-fcb17e055a0612022-09-12
43598-097-30EA - Each43598-09787466daf-4aa1-4df0-af67-bf0655b739f012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-097JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [DR. REDDYS LABORATORIES INC]4Current NDC, Legacy NDC, 2 package rows20241204_1590afa1-baa4-70e5-5a3b-468401c71044.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2611951JAVYGTOR 100 MG Powder for Oral SolutionPSN1590afa1-baa4-70e5-5a3b-468401c710444
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionPSN1590afa1-baa4-70e5-5a3b-468401c710444
2611951sapropterin dihydrochloride 100 MG Powder for Oral Solution [Javygtor]SBD1590afa1-baa4-70e5-5a3b-468401c710444
1111018sapropterin dihydrochloride 100 MG Powder for Oral SolutionSCD1590afa1-baa4-70e5-5a3b-468401c710444
2611951Javygtor 100 MG Powder for Oral SolutionSY1590afa1-baa4-70e5-5a3b-468401c710444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-097-11435980097111 in 1 PACKETHistorical
43598-097-304359800973030 PACKET in 1 CARTON (43598-097-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11) 30 packet2022-09-160000-00-00NoNoCurrent