Loratadine
- Product NDC
- 58602-423
- 11-digit product format
- 586020423
- Labeler code
- 58602
- Product ID
- 58602-423_78515214-94d8-4977-aff5-8b9beb60042e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine Oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA208931
- Marketing category
- ANDA
- Marketing start
- 2018-06-29
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- 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 | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 692783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-423-11 | Loratadine | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 6 |
| 58602-423-11 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 58602-423-24 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 58602-423-24 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-423 | LORATADINE (LORATADINE ORAL) SOLUTION [AUROHEALTH LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250124_0b86a9fe-db7e-470a-a8fa-d7d4373116ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58602-423-11 | 58602042311 | 1 BOTTLE in 1 CARTON (58602-423-11) / 60 mL in 1 BOTTLE | 1 bottle | 2018-06-29 | 0000-00-00 | No | No | Current |
| 58602-423-24 | 58602042324 | 1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLE | 1 bottle | 2018-06-29 | 0000-00-00 | No | No | Current |