Over-the-counter drug · ANDA
Loratadine NDC 50090-1454
Loratadine 5 mg/5mL · Solution · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1454-0 | 5009014540050090145400 | 120 mL in 1 CARTON (50090-1454-0)Marketed from Nov 28, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Loratadine
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077421
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-1454_06ab4a12-31b8-435c-9988-f2e1ca56003cSPL ID 06ab4a12-31b8-435c-9988-f2e1ca56003cSPL set ID 0f6fe391-8709-40f0-8f52-e3357e6ea4f9RxCUI 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.
- NDC on a medical claim
N450090145400followed by a unit qualifier and the quantityPackage 50090-1454-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
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.
About NDC 50090-1454
- What is NDC 50090-1454?
- 50090-1454 is the product NDC for Loratadine, Loratadine 5 mg/5mL solution, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine.
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loratadine?
- 107 other product NDCs are listed under this name. See all Loratadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loratadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loratadine | Loratadine 10 mg/1 | TabletOral | YYBA CORP | 73581-229 | 73581-0229-0173581-0229-03 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AvPAK | 50268-777 | 50268-0777-01 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4103 | 68788-4103-0068788-4103-0168788-4103-03+2 more |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-064 | 48433-0064-20 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-119 | 84386-0119-78 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-0142 | 82725-0142-0182725-0142-0282725-0142-03+1 more |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0188 | 55154-0188-00 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7511 | 00904-7511-61 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8659 | 68788-8659-0068788-8659-0168788-8659-03+2 more |
| Loratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Tenshi Kaizen Pvt Ltd | 72983-503 | 72983-0503-06 |
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 | ATLANTIC BIOLOGICALS CORP. | 17856-0557 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-4451 |