Azelastine Hydrochloride
- Product NDC
- 50383-942
- 11-digit product format
- 503830942
- Labeler code
- 50383
- Product ID
- 50383-942_fb3b3cc4-5848-4e70-8373-0d8a9e613e20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Akorn
- Application
- ANDA210032
- Marketing category
- ANDA
- Marketing start
- 2019-08-27
- Marketing end
- 0000-00-00
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- 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 |
|---|
| 50383-942-30 | Azelastine Hydrochloride | 30 mL in 1 BOTTLE, PUMP | SPRAY, METERED | 30 | | 10 |
| 50383-942-30 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-942 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [AKORN] | 10 | Legacy NDC, 2 package rows | 20220302_fc69f672-17ec-4d86-b5af-086fd260b512.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 |
|---|
| 50383-942-30 | 50383094230 | 1 BOTTLE, PUMP in 1 CARTON (50383-942-30) > 30 mL in 1 BOTTLE, PUMP | 2019-08-27 | 0000-00-00 | No | No | Current |