Azelastine Hydrochloride
- Product NDC
- 68083-287
- 11-digit product format
- 680830287
- Labeler code
- 68083
- Product ID
- 68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- INTRAOCULAR
- Labeler
- Gland Pharma Limited
- Application
- ANDA210092
- Marketing category
- ANDA
- Marketing start
- 2020-02-25
- 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 |
|---|
| 68083-287-01 | Azelastine Hydrochloride | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 5 |
| 68083-287-01 | Azelastine Hydrochloride | 6 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 6 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-287 | AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221011_f358cecd-284f-4d0b-806c-039465220bd2.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 |
|---|
| 68083-287-01 | 68083028701 | 1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTLE, PLASTIC | 2020-02-25 | 0000-00-00 | No | No | Current |