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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W76I6XXF06 |
| Rxcui | 2725554, 2725561 |
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 |
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 |