Loratadine
- Product NDC
- 0363-0771
- 11-digit product format
- 003630771
- Labeler code
- 0363
- Product ID
- 0363-0771_43cfee1f-c7e3-6db4-e063-6294a90a5b4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- WALGREEN COMPANY
- Application
- ANDA201865
- Marketing category
- ANDA
- Marketing start
- 2023-04-19
- 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-0771-01 | Loratadine | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 5 |
| 0363-0771-01 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 0363-0771-08 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 0363-0771-08 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0363-0771-01 | 00363077101 | 1 BOTTLE in 1 CARTON (0363-0771-01) / 240 mL in 1 BOTTLE | 1 bottle | 2023-04-19 | No | No | Current |
| 0363-0771-08 | 00363077108 | 1 BOTTLE in 1 CARTON (0363-0771-08) / 120 mL in 1 BOTTLE | 1 bottle | 2023-04-19 | No | No | Current |