Over-the-counter drug · ANDA
Loratadine NDC 17856-0557
Loratadine 5 mg/5mL · Solution · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)17856-0557Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17856-0557Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Loratadine
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077421
- Marketing start
- Listing expires
- Identifiers
- Product ID 17856-0557_4bc0edf7-fe2e-d8ab-e063-6394a90a8886SPL ID 4bc0edf7-fe2e-d8ab-e063-6394a90a8886SPL set ID 999a1080-5bbd-4027-b6e7-a90a6941ee27RxCUI 692783UNII 7AJO3BO7QN
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077421
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | NuCare Pharmaceuticals,Inc. | 68071-4451 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | Lannett Company, Inc. | 54838-554 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | Lannett Company, Inc. | 54838-558 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-1454 |