Home NDC 24338-115 JAVADIN
Product NDC 24338-115
11-digit product format 243380115
Labeler code 24338
Product ID 24338-115_c36d94f5-a30d-4997-b141-e79a4ea45ecf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride oral
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA220256
Marketing category NDA
Marketing start 2025-10-23
Substance CLONIDINE HYDROCHLORIDE
Active strength 20 ug/mL
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
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 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 N220256-001 JAVADIN CLONIDINE HYDROCHLORIDE 0.02MG/ML SOLUTION / ORAL RLD, RS 2025-10-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220256-001 12233049 2042-07-15 Drug product 2025-10-27 N220256-001 12440474 2042-07-15 Drug product 2025-10-27
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 2026-02-19 14:30 UTC 2026-02 N220256-001 JAVADIN 0.02MG/ML SOLUTION / ORAL RLD, RS 2025-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N220256-001 JAVADIN 0.02MG/ML SOLUTION / ORAL RLD, RS 2025-10-23 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220256-001 JAVADIN 0.02MG/ML SOLUTION / ORAL RLD, RS 2025-10-23 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 2026-02-19 14:30 UTC 2026-02 N220256-001 12233049 2042-07-15 Drug product 2025-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N220256-001 12440474 2042-07-15 Drug product 2025-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N220256-001 12233049 2042-07-15 Drug product 2025-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N220256-001 12440474 2042-07-15 Drug product 2025-10-27 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220256-001 12233049 2042-07-15 Drug product 2025-10-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220256-001 12440474 2042-07-15 Drug product 2025-10-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base JAVADIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE 20 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W76I6XXF06 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2725554 Internal RxNorm lookup 2725561 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 24338-115-01 JAVADIN 1 in 1 CARTON SOLUTION 1 1 24338-115-01 JAVADIN 250 mL in 1 BOTTLE SOLUTION 250 1
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 JAVADIN CLONIDINE HYDROCHLORIDE ORAL Azurity Pharmaceuticals, Inc. c36d94f5-a30d-4997-b141-e79a4ea45ecf 2025-10-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 220256 application number: NDA220256 ndc (product): 24338-115
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24338-115-01 24338011501 1 BOTTLE in 1 CARTON (24338-115-01) / 250 mL in 1 BOTTLE 1 bottle 2025-10-23 No No Current