Home NDC 43598-477 Sapropterin Dihydrochloride
Product NDC 43598-477
11-digit product format 435980477
Labeler code 43598
Product ID 43598-477_de177a71-0a19-b267-0676-34415c9d5fea
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 2021-04-01
Marketing end 0000-00-00
Substance SAPROPTERIN DIHYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43598-477-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43598-477-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43598-477-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43598-477-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43598-477-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43598-477-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43598-477-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43598-477-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43598-477-30 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209452-001 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB 2021-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209452-001 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 2026-02-19 14:30 UTC 2026-02 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER / ORAL AB 2021-03-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209452-001 SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET FOR SOLUTION / ORAL AB 2021-03-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 1590afa1-baa4-70e5-5a3b-468401c71044 2024-10-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209452 application number: ANDA209452
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-477-30 43598047730 30 PACKET in 1 CARTON (43598-477-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (43598-477-11) 30 packet 2021-04-01 0000-00-00 No No Current