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
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 | 205.5 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0L591QR10I |
| Rxcui | 1797883 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69168-479-64 | AZELASTINE HYDROCHLORIDE | 60 in 1 BOTTLE, SPRAY | SPRAY, METERED | 60 | | 2 |
| 69168-479-64 | AZELASTINE HYDROCHLORIDE | 1 in 1 CARTON | SPRAY, METERED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69168-479 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [ALLEGIANT HEALTH] | 1 | Current NDC, 2 package rows | 20250504_cc7ddac6-95fa-4bc0-824d-f80e404e8d32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |