Azelastine Hydrochloride
- Product NDC
- 60505-0833
- 11-digit product format
- 605050833
- Labeler code
- 60505
- Product ID
- 60505-0833_6ace9d74-df2e-8b53-9bc8-72a794f3a21a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelastine hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Apotex Corp.
- Application
- ANDA077954
- Marketing category
- ANDA
- Marketing start
- 2010-03-01
- 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 |
|---|
| 60505-0833-5 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | | 13 |
| 60505-0833-5 | Azelastine Hydrochloride | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZELASTINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0L591QR10I | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| AZELASTINE | ACTIVE MOIETY | ZQI909440X | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 4 | |
| azelastine hydrochloride | ACTIVE INGREDIENT | 0L591QR10I | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| azelastine | ACTIVE MOIETY | ZQI909440X | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0833 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240920_4f58c203-f649-a18e-aaf3-70b0797652f4.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 |
|---|
| 60505-0833-5 | 60505083305 | 1 BOTTLE, SPRAY in 1 CARTON (60505-0833-5) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2010-03-01 | 0000-00-00 | No | No | Current |