Home NDC 24338-103 ARYNTA
Product NDC 24338-103
11-digit product format 243380103
Labeler code 24338
Product ID 24338-103_ac355447-df74-4bb1-b0b6-1869a4846309
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lisdexamfetamine dimesylate oral
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA219847
Marketing category NDA
Marketing start 2026-03-20
Substance LISDEXAMFETAMINE DIMESYLATE
Active strength 10 mg/mL
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule CII
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 N219847-001 ARYNTA LISDEXAMFETAMINE DIMESYLATE 10MG/ML SOLUTION / ORAL RLD, RS 2025-06-16
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219847-001 12433859 2040-04-16 U-842 Drug product 2025-10-08 N219847-001 12582620 2040-04-16 Drug product 2026-03-26 N219847-001 11576878 2040-08-30 Drug product 2025-06-27
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 2026-08-01 22:54:32 2026-06 N219847-001 ARYNTA 10MG/ML SOLUTION / ORAL RLD, RS 2025-06-16 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N219847-001 12433859 2040-04-16 U-842 Drug product 2025-10-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N219847-001 12582620 2040-04-16 Drug product 2026-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N219847-001 11576878 2040-08-30 Drug product 2025-06-27 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ARYNTA LISDEXAMFETAMINE DIMESYLATE ORAL Azurity Pharmaceuticals, Inc. 71cdfc97-96af-4378-a44a-6d5d77e7d6b7 2025-07-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 219847 application number: NDA219847 ndc (product): 24338-103
Additional Listing Data#
Finished product Yes
Brand name base ARYNTA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISDEXAMFETAMINE DIMESYLATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SJT761GEGS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2726048 Internal RxNorm lookup 2726055 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 24338-103-01 ARYNTA 30 mL in 1 BOTTLE SOLUTION 30 4 24338-103-01 ARYNTA 1 in 1 CARTON SOLUTION 1 4
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24338-103-01 24338010301 1 BOTTLE in 1 CARTON (24338-103-01) / 30 mL in 1 BOTTLE 1 bottle 2026-03-20 No No Current