LORATADINE
- Product NDC
- 43598-758
- 11-digit product format
- 435980758
- Labeler code
- 43598
- Product ID
- 43598-758_2f67bf36-2053-dd83-afad-a64810fa9050
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LORATADINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA213294
- Marketing category
- ANDA
- Marketing start
- 2021-05-19
- 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 | 311373 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-758-10 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 1 |
| 43598-758-10 | LORATADINE | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 1 |
| 43598-758-30 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 1 |
| 43598-758-30 | LORATADINE | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-758 | LORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES INC.] | 1 | Current NDC, 4 package rows | 20230628_bb6af6a4-aec0-ddf5-57b7-063504ca8e1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-758-10 | 43598075810 | 1 BLISTER PACK in 1 CARTON (43598-758-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2023-07-01 | No | No | Current |
| 43598-758-30 | 43598075830 | 3 BLISTER PACK in 1 CARTON (43598-758-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2023-07-01 | No | No | Current |