Alcaftadine
- Product NDC
- 58602-605
- 11-digit product format
- 586020605
- Labeler code
- 58602
- Product ID
- 58602-605_d550d462-ab7c-4703-9e6d-3b2360abac7d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alcaftadine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aurohealth LLC
- Application
- ANDA210659
- Marketing category
- ANDA
- Marketing start
- 2023-06-23
- Substance
- ALCAFTADINE
- Active strength
- 2.5 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
- Alcaftadine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALCAFTADINE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7Z8O94ECSX |
| Rxcui | 1000085 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-605-40 | Alcaftadine | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
| 58602-605-40 | Alcaftadine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 58602-605-42 | Alcaftadine | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | | 1 |
| 58602-605-42 | Alcaftadine | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-605 | ALCAFTADINE SOLUTION/ DROPS [AUROHEALTH LLC] | 1 | Current NDC, 4 package rows | 20230628_d550d462-ab7c-4703-9e6d-3b2360abac7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58602-605-40 | 58602060540 | 1 BOTTLE in 1 CARTON (58602-605-40) / 5 mL in 1 BOTTLE | 1 bottle | 2023-06-23 | No | No | Current |
| 58602-605-42 | 58602060542 | 2 BOTTLE in 1 CARTON (58602-605-42) / 5 mL in 1 BOTTLE | 2 bottle | 2023-06-23 | No | No | Current |