Home NDC 49884-720 sapropterin dihydrochloride
Product NDC 49884-720
11-digit product format 498840720
Labeler code 49884
Product ID 49884-720_613f1a86-4523-4a35-ad6b-38ef403f7971
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sapropterin dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Par Health USA, LLC
Application ANDA207200
Marketing category ANDA
Marketing start 2020-10-01
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 2027-12-31
Current FDA listing Yes 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 A207200-001 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207200-001 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.
Product history page 1 of 2 · 41 observed 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 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL 2019-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL 2019-05-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL 2019-05-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL 2019-05-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207200-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2019-05-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A207200-001 PC 2021-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207200-001 PC 2021-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207200-001 PC 2021-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207200-001 PC 2021-03-30 8869cabd3fbd…
Additional Listing Data#
Finished product Yes
Brand name base sapropterin dihydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAPROPTERIN DIHYDROCHLORIDE 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1486687 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 49884-720-08 sapropterin dihydrochloride 120 in 1 BOTTLE TABLET 120 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-720 SAPROPTERIN DIHYDROCHLORIDE TABLET [ENDO USA, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240820_eafec3a2-4f29-4afa-8728-a62b34cefd18.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.
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 49884-720-08 49884072008 120 TABLET in 1 BOTTLE (49884-720-08) 120 tablet 2020-10-01 0000-00-00 No No Current