AZELASTINE HYDROCHLORIDE
- Product NDC
- 50090-7461
- 11-digit product format
- 500907461
- Labeler code
- 50090
- Product ID
- 50090-7461_6f0629d0-5f20-406f-ad61-cf775f553772
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA212289
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 137 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 |
|---|
| 50090-7461-0 | 50090746100 | 1 BOTTLE, SPRAY in 1 CARTON (50090-7461-0) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2024-11-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| AZELASTINE HYDROCHLORIDE | A-S Medication Solutions | 2024-11-20 | Human Prescription Drug Label | 1 |