Loratadine
- Product NDC
- 55154-0188
- 11-digit product format
- 551540188
- Labeler code
- 55154
- Product ID
- 55154-0188_53fbf8c1-cbfb-4440-94d2-9662f2cc9ca2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2025-08-28
- 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 |
|---|
| 55154-0188-0 | Loratadine | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 55154-0188-0 | Loratadine | 10 in 1 BAG | 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 |
|---|
| 55154-0188-0 | 55154018800 | 10 BLISTER PACK in 1 BAG (55154-0188-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2025-08-28 | No | No | Current |