AZELASTINE HYDROCHLORIDE
- Product NDC
- 76519-1222
- 11-digit product format
- 765191222
- Labeler code
- 76519
- Product ID
- 76519-1222_826e1b87-e59b-8637-e053-2991aa0aded1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA090176
- Marketing category
- ANDA
- Marketing start
- 2019-02-12
- Marketing end
- 0000-00-00
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 137 ug/.137mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 76519-1222-0 | AZELASTINE HYDROCHLORIDE | 30 mL in 1 BOTTLE, SPRAY | SPRAY, METERED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1222 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 1 package rows | 20190222_826e1b87-e59a-8637-e053-2991aa0aded1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76519-1222-0 | 76519122200 | 30 mL in 1 BOTTLE, SPRAY (76519-1222-0) | 30 ml | 2019-02-12 | 0000-00-00 | No | No | Current |