Azelastine HCl
- Product NDC
- 69238-2147
- 11-digit product format
- 692382147
- Labeler code
- 69238
- Product ID
- 69238-2147_125e35a1-2e6f-4646-aad2-d6465917671c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Azelastine
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216576
- Marketing category
- ANDA
- Marketing start
- 2024-06-07
- 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 HCl
- 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 |
|---|
| 69238-2147-3 | Azelastine HCl | 1 in 1 CARTON | SPRAY, METERED | 1 | | 10 |
| 69238-2147-3 | Azelastine HCl | 200 in 1 BOTTLE | SPRAY, METERED | 200 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-2147 | AZELASTINE HCL (AZELASTINE) SPRAY, METERED [AMNEAL PHARMACEUTICALS NY LLC] | 9 | Current NDC, 2 package rows | 20240608_82610437-25f4-4ae0-9d6a-381e9932f87d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-2147-3 | 69238214703 | 200 CARTON in 1 BOTTLE (69238-2147-3) / 1 SPRAY, METERED in 1 CARTON | 200 carton | 2024-06-07 | No | No | Current |