Azelastine Hydrochloride
- Product NDC
- 68788-4056
- 11-digit product format
- 687884056
- Labeler code
- 68788
- Product ID
- 68788-4056_a2ba9c1d-b21f-4816-bbe6-949a49e38572
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelastine hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077954
- Marketing category
- ANDA
- Marketing start
- 2025-11-17
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azelastine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELASTINE HYDROCHLORIDE | 137 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0L591QR10I |
| Rxcui | 1797867 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4056-2 | Azelastine Hydrochloride | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 1 |
| 68788-4056-2 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4056-2 | 68788405602 | 1 BOTTLE, SPRAY in 1 CARTON (68788-4056-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-11-17 | No | No | Historical |