Alcaftadine
- Product NDC
- 68083-649
- 11-digit product format
- 680830649
- Labeler code
- 68083
- Product ID
- 68083-649_8c937f90-5ae8-49e9-808d-f3dbd9da1882
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alcaftadine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA209706
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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 |
|---|
| 68083-649-01 | Alcaftadine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 68083-649-01 | Alcaftadine | 3 mL in 1 BOTTLE | SOLUTION/ DROPS | 3 | | 3 |
| 68083-649-02 | Alcaftadine | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | | 3 |
| 68083-649-02 | Alcaftadine | 3 mL in 1 BOTTLE | SOLUTION/ DROPS | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-649 | ALCAFTADINE SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 3 | Current NDC, 4 package rows | 20240307_b94e071d-421d-48ec-a4ea-254aa8af19ff.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 |
|---|
| 68083-649-01 | 68083064901 | 1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE | 1 bottle | 2024-03-01 | No | No | Current |
| 68083-649-02 | 68083064902 | 2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE | 2 bottle | 2024-03-01 | No | No | Current |