Home NDC 43598-162 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215798-001 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB 2022-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215798-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB 2022-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER / ORAL AB 2022-05-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215798-001 SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET FOR SOLUTION / ORAL AB 2022-05-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base JAVYGTOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAPROPTERIN DIHYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RG277LF5B3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1653217 Internal RxNorm lookup 2621237 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-162-11 JAVYGTOR 1 in 1 PACKET POWDER, FOR SOLUTION 1 4 43598-162-30 JAVYGTOR 30 in 1 CARTON POWDER, FOR SOLUTION 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-162 JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [DR. REDDYS LABORATORIES INC] 4 Current NDC, Legacy NDC, 2 package rows 20250123_eecdd8c7-5f8a-0af1-793a-db2e2ba0f491.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join JAVYGTOR SAPROPTERIN DIHYDROCHLORIDE Dr. Reddys Laboratories Inc eecdd8c7-5f8a-0af1-793a-db2e2ba0f491 2024-10-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215798 application number: ANDA215798 ndc (product): 43598-162
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-162-11 43598016211 1 in 1 PACKET Historical 43598-162-30 43598016230 30 PACKET in 1 CARTON (43598-162-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-162-11) 30 packet 2022-11-16 0000-00-00 No No Current