Loratadine
- Product NDC
- 58602-831
- 11-digit product format
- 586020831
- Labeler code
- 58602
- Product ID
- 58602-831_de409efa-eff4-47fb-a6c6-a22be0587553
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2018-04-16
- 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 |
|---|
| 58602-831-17 | Loratadine | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 58602-831-17 | Loratadine | 45 in 1 BOTTLE | TABLET | 45 | | 3 |
| 58602-831-19 | Loratadine | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 58602-831-19 | Loratadine | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-831 | LORATADINE TABLET [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20221104_839e2e03-9ebb-4a44-b753-fb174bd36115.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 |
|---|
| 58602-831-17 | 58602083117 | 1 BOTTLE in 1 CARTON (58602-831-17) / 45 TABLET in 1 BOTTLE | 1 bottle | 2018-04-16 | 0000-00-00 | No | No | Current |
| 58602-831-19 | 58602083119 | 1 BOTTLE in 1 CARTON (58602-831-19) / 90 TABLET in 1 BOTTLE | 1 bottle | 2018-04-16 | 0000-00-00 | No | No | Current |