Home NDC 24338-160 ARYNTA
Product NDC 24338-160
11-digit product format 243380160
Labeler code 24338
Product ID 24338-160_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 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 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 2026-08-18 06:07:40 2026-07 N219847-001 ARYNTA 10MG/ML SOLUTION / ORAL RLD, RS 2025-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219847-001 ARYNTA 10MG/ML SOLUTION / ORAL RLD, RS 2025-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219847-001 ARYNTA 10MG/ML SOLUTION / ORAL RLD, RS 2025-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219847-001 ARYNTA 10MG/ML SOLUTION / ORAL RLD, RS 2025-06-16 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 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 2026-08-18 06:07:40 2026-07 N219847-001 12433859 2040-04-16 U-842 Drug product 2025-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219847-001 12582620 2040-04-16 Drug product 2026-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219847-001 11576878 2040-08-30 Drug product 2025-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219847-001 12433859 2040-04-16 U-842 Drug product 2025-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219847-001 11576878 2040-08-30 Drug product 2025-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219847-001 12433859 2040-04-16 U-842 Drug product 2025-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219847-001 11576878 2040-08-30 Drug product 2025-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219847-001 11576878 2040-08-30 Drug product 2025-06-27 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219847-001 12433859 2040-04-16 U-842 Drug product 2025-10-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219847-001 12582620 2040-04-16 Drug product 2026-03-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219847-001 11576878 2040-08-30 Drug product 2025-06-27 a50c72e98297…
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 24338-160-01 ARYNTA 60 mL in 1 BOTTLE SOLUTION 60 4 24338-160-01 ARYNTA 1 in 1 CARTON SOLUTION 1 4
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 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): 24338-160
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24338-160-01 24338016001 1 BOTTLE in 1 CARTON (24338-160-01) / 60 mL in 1 BOTTLE 1 bottle 2026-03-20 No No Current