FDA.reportPublic FDA data

JAVYGTOR

Product NDC
43598-162
11-digit product format
435980162
Labeler code
43598
Product ID
43598-162_d7031ea9-d03c-02fb-c066-2aa0a4ca39fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sapropterin Dihydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA215798
Marketing category
ANDA
Marketing start
2022-11-16
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
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 DIHYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1653217, 2621237

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-162-11JAVYGTOR1 in 1 PACKETPOWDER, FOR SOLUTION14
43598-162-30JAVYGTOR30 in 1 CARTONPOWDER, FOR SOLUTION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-162-11EA - Each43598-162ad638a3a-b698-4416-9a49-7340f8ded50e12022-12-07
43598-162-30EA - Each43598-1620b2bfe99-d1f7-46ec-b3c9-5dff5f24f4f612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-162JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [DR. REDDYS LABORATORIES INC]4Current NDC, Legacy NDC, 2 package rows20250123_eecdd8c7-5f8a-0af1-793a-db2e2ba0f491.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2621237JAVYGTOR 500 MG Powder for Oral SolutionPSNeecdd8c7-5f8a-0af1-793a-db2e2ba0f4914
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSNeecdd8c7-5f8a-0af1-793a-db2e2ba0f4914
2621237sapropterin dihydrochloride 500 MG Powder for Oral Solution [Javygtor]SBDeecdd8c7-5f8a-0af1-793a-db2e2ba0f4914
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCDeecdd8c7-5f8a-0af1-793a-db2e2ba0f4914
2621237Javygtor 500 MG Powder for Oral SolutionSYeecdd8c7-5f8a-0af1-793a-db2e2ba0f4914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-162-11435980162111 in 1 PACKETHistorical
43598-162-304359801623030 PACKET in 1 CARTON (43598-162-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-162-11) 30 packet2022-11-160000-00-00NoNoCurrent