Azelastine Hydrochloride
- Product NDC
- 50383-738
- 11-digit product format
- 503830738
- Labeler code
- 50383
- Product ID
- 50383-738_d40cbc85-2350-41e1-86ee-7b20c2e0e885
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Akorn
- Application
- ANDA207610
- Marketing category
- ANDA
- Marketing start
- 2019-05-18
- Marketing end
- 0000-00-00
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-738-30 | 50383073830 | 1 BOTTLE in 1 CARTON (50383-738-30) > 30 mL in 1 BOTTLE | 1 bottle | 2019-05-18 | 0000-00-00 | No | No | Current |