Loratadine
- Product NDC
- 68001-449
- 11-digit product format
- 680010449
- Labeler code
- 68001
- Product ID
- 68001-449_352cf9e6-9f6c-b81e-e063-6394a90a397f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine Oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA208931
- Marketing category
- ANDA
- Marketing start
- 2020-07-31
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 692783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-449-98 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 68001-449-98 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-449 | LORATADINE (LORATADINE ORAL) SOLUTION [BLUEPOINT LABORATORIES] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250519_ab820f80-b5fc-7896-e053-2995a90a4b1c.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 |
|---|
| 68001-449-98 | 68001044998 | 1 BOTTLE in 1 CARTON (68001-449-98) / 120 mL in 1 BOTTLE | 1 bottle | 2020-07-31 | 0000-00-00 | No | No | Current |