Loratadine ODT
- Product NDC
- 58602-821
- 11-digit product format
- 586020821
- Labeler code
- 58602
- Product ID
- 58602-821_7564581a-2a15-4c0e-8ae9-459a760613a9
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-821-83 | Loratadine ODT | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 3 |
| 58602-821-83 | Loratadine ODT | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 3 |
| 58602-821-84 | Loratadine ODT | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 3 |
| 58602-821-84 | Loratadine ODT | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-821 | LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20221104_9f44382f-c289-402d-bb98-ec5fa80fc25d.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 |
|---|
| 58602-821-83 | 58602082183 | 1 BLISTER PACK in 1 CARTON (58602-821-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2018-04-11 | 0000-00-00 | No | No | Current |
| 58602-821-84 | 58602082184 | 3 BLISTER PACK in 1 CARTON (58602-821-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2018-04-11 | 0000-00-00 | No | No | Current |