Childrens Loratadine Oral
- Product NDC
- 50090-7516
- 11-digit product format
- 500907516
- Labeler code
- 50090
- Product ID
- 50090-7516_c7f2a0cc-cb60-41d0-9370-b05c5fd5e7d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075728
- Marketing category
- ANDA
- Marketing start
- 2019-02-12
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Loratadine Oral
- Listing expiration
- 2027-12-31
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 |
|---|
| 50090-7516-0 | Childrens Loratadine Oral | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 3 |
| 50090-7516-0 | Childrens Loratadine Oral | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7516 | CHILDRENS LORATADINE ORAL (LORATADINE) SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20250315_0a42baae-554b-4b93-8780-fe45c42fabc0.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 |
|---|
| 50090-7516-0 | 50090751600 | 1 BOTTLE in 1 CARTON (50090-7516-0) / 120 mL in 1 BOTTLE | 1 bottle | 2025-03-10 | No | No | Historical |