Loratadine
- Product NDC
- 72983-500
- 11-digit product format
- 729830500
- Labeler code
- 72983
- Product ID
- 72983-500_0df0dfde-1f52-4769-e063-6394a90a2f92
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Tenshi Kaizen Pvt Ltd
- Application
- ANDA212795
- Marketing category
- ANDA
- Marketing start
- 2021-05-19
- Substance
- LORATADINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 672558 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72983-500-01 | Loratadine | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 72983-500-01 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72983-500 | LORATADINE TABLET [TENSHI KAIZEN PVT LTD] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240102_c20b91e0-ef92-6f2f-e053-2a95a90a2a36.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 |
|---|
| 72983-500-01 | 72983050001 | 1 BLISTER PACK in 1 CARTON (72983-500-01) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2021-05-19 | 0000-00-00 | No | No | Current |