AZELASTINE HYDROCHLORIDE
- Product NDC
- 69168-479
- 11-digit product format
- 691680479
- Labeler code
- 69168
- Product ID
- 69168-479_a38d6984-143a-4e7e-802a-269070c5e13e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Allegiant Health
- Application
- ANDA216421
- Marketing category
- ANDA
- Marketing start
- 2025-05-02
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 205.5 ug/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0L591QR10I | AZELASTINE HYDROCHLORIDE | 79307-93-0 | AZELASTINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69168-479-64 | 69168047964 | 1 BOTTLE, SPRAY in 1 CARTON (69168-479-64) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-05-02 | No | No | Historical |