Loratadine
- Product NDC
- 84386-119
- 11-digit product format
- 843860119
- Labeler code
- 84386
- Product ID
- 84386-119_4f4ffb72-f4e8-4617-8bc5-61e6de488a2d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2025-11-12
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- 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 |
|---|
| 84386-119-78 | 84386011978 | 10 BLISTER PACK in 1 CARTON (84386-119-78) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2025-11-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Loratadine Tablets USP 10 mg | Aurobindo Pharma Limited | Aurohealth LLC | 2025-11-12 | Human OTC Drug Label | 1 |