AZELASTINE HYDROCHLORIDE
- Product NDC
- 72603-611
- 11-digit product format
- 726030611
- Labeler code
- 72603
- Product ID
- 72603-611_cb0aca6d-ff9c-4239-8681-d212a6764ba9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA212289
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- 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 |
|---|
| 72603-611-01 | AZELASTINE HYDROCHLORIDE | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 1 |
| 72603-611-01 | 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 |
|---|
| 72603-611-01 | 72603061101 | 1 BOTTLE, SPRAY in 1 CARTON (72603-611-01) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-07-01 | No | No | Historical |