Loratadine
- Product NDC
- 0363-0771
- 11-digit product format
- 003630771
- Labeler code
- 0363
- Product ID
- 0363-0771_43cfee1f-c7e3-6db4-e063-6294a90a5b4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- WALGREEN COMPANY
- Application
- ANDA201865
- Marketing category
- ANDA
- Marketing start
- 2023-04-19
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Sample | Exclude flag | Status |
|---|
| 0363-0771-01 | 00363077101 | 1 BOTTLE in 1 CARTON (0363-0771-01) / 240 mL in 1 BOTTLE | 1 bottle | 2023-04-19 | No | No | Historical |
| 0363-0771-08 | 00363077108 | 1 BOTTLE in 1 CARTON (0363-0771-08) / 120 mL in 1 BOTTLE | 1 bottle | 2023-04-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Loratadine | WALGREEN COMPANY | 2025-11-17 | HUMAN OTC DRUG LABEL | 5 |
| Loratadine | WALGREEN COMPANY | 2023-10-13 | HUMAN OTC DRUG LABEL | 3 |