Loratadine
- Product NDC
- 43353-259
- 11-digit product format
- 433530259
- Labeler code
- 43353
- Product ID
- 43353-259_15aaaeb4-fda5-f5e2-e063-6394a90a47ee
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2008-10-15
- 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
- Brand name suffix
- antihistamine
- 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 | 311372 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-259-09 | Loratadineantihistamine | 9000 in 1 BOTTLE | TABLET | 9000 | | 5 |
| 43353-259-18 | Loratadineantihistamine | 3000 in 1 BOTTLE | TABLET | 3000 | | 5 |
| 43353-259-60 | Loratadineantihistamine | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-259 | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240410_a2c92766-df4e-4414-9c42-e18bcf9db6b4.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 |
|---|
| 43353-259-09 | 43353025909 | 9000 TABLET in 1 BOTTLE (43353-259-09) | 9000 tablet | 2022-09-08 | 0000-00-00 | No | No | Current |
| 43353-259-18 | 43353025918 | 3000 TABLET in 1 BOTTLE (43353-259-18) | 3000 tablet | 2022-10-17 | 0000-00-00 | No | No | Current |
| 43353-259-30 | 43353025930 | 30 TABLET in 1 BOTTLE (43353-259-30) | 30 tablet | 2017-01-17 | 0000-00-00 | No | No | Current |
| 43353-259-60 | 43353025960 | 90 TABLET in 1 BOTTLE (43353-259-60) | 90 tablet | 2016-11-23 | 0000-00-00 | No | No | Current |