AZELASTINE HYDROCHLORIDE
- Product NDC
- 51991-814
- 11-digit product format
- 519910814
- Labeler code
- 51991
- Product ID
- 51991-814_00b0d20e-8d18-4336-a966-6add80268c8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA090176
- Marketing category
- ANDA
- Marketing start
- 2015-07-29
- Marketing end
- 2024-12-31
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 137 ug/.137mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-814-03 | 51991081403 | 1 BOTTLE, SPRAY in 1 CARTON (51991-814-03) > 30 mL in 1 BOTTLE, SPRAY | 2015-07-29 | 2024-12-31 | No | No | Current |