Loratadine
- Product NDC
- 82501-1580
- 11-digit product format
- 825011580
- Labeler code
- 82501
- Product ID
- 82501-1580_2c81c9aa-35e4-6008-e063-6294a90a9bc9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gobrands, Inc
- Application
- ANDA214684
- Marketing category
- ANDA
- Marketing start
- 2022-05-16
- 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 |
|---|
| 82501-1580-3 | Loratadine | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 82501-1580-3 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82501-1580 | LORATADINE TABLET [GOBRANDS, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250126_1d182bd6-ad72-4352-b983-407a48c317f0.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 |
|---|
| 82501-1580-3 | 82501158003 | 1 BOTTLE in 1 CARTON (82501-1580-3) / 30 TABLET in 1 BOTTLE | 1 bottle | 2022-05-16 | 0000-00-00 | No | No | Current |