Loratadine
- Product NDC
- 80425-0352
- 11-digit product format
- 804250352
- Labeler code
- 80425
- Product ID
- 80425-0352_2a9c2eb6-a6de-f647-e063-6294a90a93fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA214684
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- 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 | 311372 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0352-1 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0352 | LORATADINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 1 package rows | 20250102_01cb43cf-57a9-f189-e063-6294a90afd88.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 |
|---|
| 80425-0352-1 | 80425035201 | 30 TABLET in 1 BOTTLE (80425-0352-1) | 30 tablet | 2023-07-31 | No | No | Historical |