Loratadine ODT
- Product NDC
- 58602-830
- 11-digit product format
- 586020830
- Labeler code
- 58602
- Product ID
- 58602-830_5c099ee7-0679-45af-ac3d-d8e77d12e809
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA208477
- Marketing category
- ANDA
- Marketing start
- 2018-04-11
- 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 ODT
- 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 | 311373 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-830-83 | Loratadine ODT | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 3 |
| 58602-830-83 | Loratadine ODT | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-830 | LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221104_1ba8e521-0b0f-419c-b7c3-fa9586f83f36.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 |
|---|
| 58602-830-83 | 58602083083 | 1 BLISTER PACK in 1 CARTON (58602-830-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2018-04-11 | 0000-00-00 | No | No | Current |