Azelastine Hydrochloride
- Product NDC
- 53002-2279
- 11-digit product format
- 530022279
- Labeler code
- 53002
- Product ID
- 53002-2279_0aa49847-53d6-4cea-904f-535a315a4b59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090423
- Marketing category
- ANDA
- Marketing start
- 2012-05-24
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2279-1 | Azelastine Hydrochloride | 1 in 1 BOX | SPRAY, METERED | 1 | | 1 |
| 53002-2279-1 | Azelastine Hydrochloride | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2279 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20220331_2ffdc506-c432-405c-91d5-0cabe7bcbf86.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-2279-1 | 53002227901 | 1 BOTTLE, SPRAY in 1 BOX (53002-2279-1) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2021-01-01 | 0000-00-00 | No | No | Current |