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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine
- Listing expiration
- 2026-12-31
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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-119-78 | Loratadine | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 84386-119-78 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |