Loratadine
- Product NDC
- 71610-423
- 11-digit product format
- 716100423
- Labeler code
- 71610
- Product ID
- 71610-423_c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2018-12-06
- 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 |
|---|
| 71610-423-60 | 71610042360 | 90 TABLET in 1 BOTTLE (71610-423-60) | 90 tablet | 2020-05-01 | No | No | Historical |