LORATADINE
- Product NDC
- 72983-503
- 11-digit product format
- 729830503
- Labeler code
- 72983
- Product ID
- 72983-503_17deb249-05f1-80b0-e063-6294a90a2535
- 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
- 2024-05-07
- 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 |
|---|
| 72983-503-06 | LORATADINE | 60 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 60 | | 1 |
| 72983-503-06 | LORATADINE | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72983-503 | LORATADINE TABLET, ORALLY DISINTEGRATING [TENSHI KAIZEN PVT LTD] | 1 | Current NDC, 2 package rows | 20240508_9c168fbb-6668-4a9d-9c7e-d3441e60eb95.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 |
|---|
| 72983-503-06 | 72983050306 | 60 BLISTER PACK in 1 CARTON (72983-503-06) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 60 blister pack | 2024-05-07 | No | No | Historical |