LORATADINE
- Product NDC
- 72983-501
- 11-digit product format
- 729830501
- Labeler code
- 72983
- Product ID
- 72983-501_0df121d3-d784-620c-e063-6294a90acdab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LORATADINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Tenshi Kaizen Pvt Ltd
- 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 |
|---|
| 72983-501-01 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 5 |
| 72983-501-01 | LORATADINE | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 5 |
| 72983-501-03 | LORATADINE | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 5 |
| 72983-501-03 | LORATADINE | 30 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72983-501 | LORATADINE TABLET, ORALLY DISINTEGRATING [TENSHI KAIZEN PVT LTD] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240102_c20b916d-7dd0-1a56-e053-2995a90a3c1b.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 |
|---|
| 72983-501-01 | 72983050101 | 1 BLISTER PACK in 1 CARTON (72983-501-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2021-05-19 | 0000-00-00 | No | No | Current |
| 72983-501-03 | 72983050103 | 3 BLISTER PACK in 1 CARTON (72983-501-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2021-05-19 | 0000-00-00 | No | No | Current |