Loratadine
- Product NDC
- 69848-019
- 11-digit product format
- 698480019
- Labeler code
- 69848
- Product ID
- 69848-019_469099a1-3de4-d107-e063-6294a90adf16
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GRANULES USA, INC.
- Application
- ANDA210722
- Marketing category
- ANDA
- Marketing start
- 2021-07-26
- 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 |
|---|
| 69848-019-10 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69848-019 | LORATADINE TABLET [GRANULES USA, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241212_c3c9bc45-7ed5-abf4-e053-2995a90a40ff.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 |
|---|
| 69848-019-10 | 69848001910 | 100 TABLET in 1 BOTTLE (69848-019-10) | 100 tablet | 2021-07-26 | 0000-00-00 | No | No | Current |