Childrens Loratadine Oral
- Product NDC
- 0904-6767
- 11-digit product format
- 009046767
- Labeler code
- 0904
- Product ID
- 0904-6767_efdb406d-9562-4ed6-b461-683c82e26a73
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075728
- Marketing category
- ANDA
- Marketing start
- 2019-02-12
- 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
- Childrens Loratadine Oral
- 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 |
|---|
| 0904-6767-20 | Childrens Loratadine Oral | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 4 |
| 0904-6767-20 | Childrens Loratadine Oral | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6767 | CHILDRENS LORATADINE ORAL (LORATADINE) SOLUTION [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250507_3f0f0131-b516-4ff3-8049-3d3766324b66.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 |
|---|
| 0904-6767-20 | 00904676720 | 1 BOTTLE in 1 CARTON (0904-6767-20) / 120 mL in 1 BOTTLE | 1 bottle | 2019-02-12 | 0000-00-00 | No | No | Current |