Over-the-counter drug · ANDA
Loratadine (Loratadine oral) NDC 58602-423
Loratadine 5 mg/5mL · Solution · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-423-11 | 5860204231158602042311 | 1 BOTTLE in 1 CARTON (58602-423-11) / 60 mL in 1 BOTTLEMarketed from Jun 29, 2018 | |
| 58602-423-24 | 5860204232458602042324 | 1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLEMarketed from Jun 29, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 oral
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208931
- Marketing start
- Listing expires
- Identifiers
- Product ID 58602-423_78515214-94d8-4977-aff5-8b9beb60042eSPL ID 78515214-94d8-4977-aff5-8b9beb60042eSPL set ID 0b86a9fe-db7e-470a-a8fa-d7d4373116baRxCUI 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
N458602042311followed by a unit qualifier and the quantityPackage 58602-0423-11. 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 58602-423
- What is NDC 58602-423?
- 58602-423 is the product NDC for Loratadine (loratadine oral), Loratadine 5 mg/5mL solution, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine (Loratadine Oral).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. 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 208931
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 |
|---|---|---|---|---|
| Loratadineloratadine oral | Loratadine 5 mg/5mL | SolutionOral | Better Living Brands LLC | 21130-042 |
| Loratadineloratadine oral | Loratadine 5 mg/5mL | SolutionOral | KROGER COMPANY | 30142-062 |
| Loratadineloratadine oral | Loratadine 5 mg/5mL | SolutionOral | BluePoint Laboratories | 68001-449 |