Azelastine Hydrochloride
- Product NDC
- 70069-091
- 11-digit product format
- 700690091
- Labeler code
- 70069
- Product ID
- 70069-091_9d82b566-97da-4162-a649-b44f3e516d9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA207411
- Marketing category
- ANDA
- Marketing start
- 2019-04-08
- 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
- 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 |
|---|
| 70069-091-01 | Azelastine Hydrochloride | 6 mL in 1 BOTTLE | SOLUTION/ DROPS | 6 | | 7 |
| 70069-091-01 | Azelastine Hydrochloride | 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 |
|---|
| 70069-091 | AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230317_72406ded-7886-41fb-b5c8-2d27a149aa34.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 |
|---|
| 70069-091-01 | 70069009101 | 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE | 1 bottle | 2019-04-08 | 0000-00-00 | No | No | Current |