Azelastine Hydrochloride
- Product NDC
- 53002-1279
- 11-digit product format
- 530021279
- Labeler code
- 53002
- Product ID
- 53002-1279_b3c84bb1-5300-41f2-889b-888bc41b6db3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelastine hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077954
- Marketing category
- ANDA
- Marketing start
- 2010-03-01
- 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
- 2021-12-31
- 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 |
|---|
| 53002-1279-1 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | | 3 |
| 53002-1279-1 | Azelastine Hydrochloride | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1279 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20230609_06ac404a-aa75-413d-b85b-d5e07b1b82cd.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 |
|---|
| 53002-1279-1 | 53002127901 | 1 BOTTLE, SPRAY in 1 CARTON (53002-1279-1) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2020-01-01 | 0000-00-00 | No | No | Current |