Azelastine Hydrochloride
- Product NDC
- 50090-3833
- 11-digit product format
- 500903833
- Labeler code
- 50090
- Product ID
- 50090-3833_77224ee2-6d31-4a78-96c2-5f2f19a41499
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA204660
- Marketing category
- ANDA
- Marketing start
- 2017-09-05
- Marketing end
- 0000-00-00
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 50090-3833-0 | Azelastine Hydrochloride | 30 mL in 1 BOTTLE, SPRAY | SPRAY, METERED | 30 | | 5 |
| 50090-3833-0 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3833 | AZELASTINE HYDROCHLORIDE (AZELASTINE) SPRAY, METERED [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 2 package rows | 20210417_a710e553-9ce8-4c92-a186-1649ec10b88d.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 |
|---|
| 50090-3833-0 | 50090383300 | 1 BOTTLE, SPRAY in 1 CARTON (50090-3833-0) > 30 mL in 1 BOTTLE, SPRAY | 2018-11-14 | 0000-00-00 | No | No | Current |