Loratadine
- Product NDC
- 0615-8503
- 11-digit product format
- 006158503
- Labeler code
- 0615
- Product ID
- 0615-8503_2d41bcf4-af71-4335-8d7c-2d14b5e12706
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2008-10-15
- Marketing end
- 2026-08-31
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Loratadine
- Brand name suffix
- antihistamine
Active Ingredients
| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311372 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7AJO3BO7QN | LORATADINE | 79794-75-5 | LORATADINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8503-39 | 00615850339 | 30 TABLET in 1 BLISTER PACK (0615-8503-39) | 30 tablet | 2024-01-29 | 2026-08-31 | No | No | Historical |