Azelastine Hydrochloride Ophthalmic Solution 0.05%
- Product NDC
- 62332-506
- 11-digit product format
- 623320506
- Labeler code
- 62332
- Product ID
- 62332-506_0857a4e2-caec-4c87-9894-949a549144c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride Ophthalmic Solution 0.05%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA209620
- Marketing category
- ANDA
- Marketing start
- 2019-03-20
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- .5 mg/mL
- 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 Ophthalmic Solution 0.05%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELASTINE HYDROCHLORIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0L591QR10I |
| Rxcui | 860805 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-506-06 | Azelastine Hydrochloride Ophthalmic Solution 0.05% | 6 mL in 1 BOTTLE | SOLUTION/ DROPS | 6 | | 7 |
| 62332-506-06 | Azelastine Hydrochloride Ophthalmic Solution 0.05% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-506 | AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250104_7532ed82-5cfa-49da-83e5-c57ffdd3adbb.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 |
|---|
| 62332-506-06 | 62332050606 | 1 BOTTLE in 1 CARTON (62332-506-06) / 6 mL in 1 BOTTLE | 1 bottle | 2019-03-20 | 0000-00-00 | No | No | Current |