Loratadine
- Product NDC
- 68788-4103
- 11-digit product format
- 687884103
- Labeler code
- 68788
- Product ID
- 68788-4103_7ca5050a-328a-4aff-8954-58f092e3ed6b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2026-04-21
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311372 |
DailyMed Package Descriptions#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4103-0 | 68788410300 | 10 TABLET in 1 BOTTLE (68788-4103-0) | 10 tablet | 2026-04-21 | No | No | Historical |
| 68788-4103-1 | 68788410301 | 14 TABLET in 1 BOTTLE (68788-4103-1) | 14 tablet | 2026-04-21 | No | No | Historical |
| 68788-4103-3 | 68788410303 | 30 TABLET in 1 BOTTLE (68788-4103-3) | 30 tablet | 2026-04-21 | No | No | Historical |
| 68788-4103-5 | 68788410305 | 15 TABLET in 1 BOTTLE (68788-4103-5) | 15 tablet | 2026-04-21 | No | No | Historical |
| 68788-4103-9 | 68788410309 | 90 TABLET in 1 BOTTLE (68788-4103-9) | 90 tablet | 2026-04-21 | No | No | Historical |