Azelastine Hydrochloride
- Product NDC
- 47335-779
- 11-digit product format
- 473350779
- Labeler code
- 47335
- Product ID
- 47335-779_09652cb1-7315-4188-9f36-4e2b50fb764d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090423
- Marketing category
- ANDA
- Marketing start
- 2012-05-24
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azelastine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELASTINE HYDROCHLORIDE | 137 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0L591QR10I |
| Rxcui | 1797867 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-779-91 | Azelastine Hydrochloride | 1 in 1 BOX | SPRAY, METERED | 1 | | 9 |
| 47335-779-91 | Azelastine Hydrochloride | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZELASTINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0L591QR10I | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| AZELASTINE | ACTIVE MOIETY | ZQI909440X | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-779 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20181214_305c6dc8-8247-473d-9975-b02903af6d53.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 |
|---|
| 47335-779-91 | 47335077991 | 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2012-05-24 | 0000-00-00 | No | No | Current |