Over-the-counter drug · ANDA
Loratadine NDC 0363-0771
Loratadine 5 mg/5mL · Solution · Oral · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0771-01 | 00363077101 | 1 BOTTLE in 1 CARTON (0363-0771-01) / 240 mL in 1 BOTTLEMarketed from Apr 19, 2023 | |
| 0363-0771-08 | 00363077108 | 1 BOTTLE in 1 CARTON (0363-0771-08) / 120 mL in 1 BOTTLEMarketed from Apr 19, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- WALGREEN COMPANYNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201865
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-0771_43cfee1f-c7e3-6db4-e063-6294a90a5b4dSPL ID 43cfee1f-c7e3-6db4-e063-6294a90a5b4dSPL set ID 3881afaf-8d0d-4154-85a8-79a3c7806b49RxCUI 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
N400363077101followed by a unit qualifier and the quantityPackage 00363-0771-01. 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 sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 0363-0771
- What is NDC 0363-0771?
- 0363-0771 is the product NDC for Loratadine, Loratadine 5 mg/5mL solution, listed with the FDA by WALGREEN COMPANY. It has 2 package NDCs, 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?
- WALGREEN COMPANY, NDC labeler code 0363. 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?
- 108 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 201865
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 |
|---|---|---|---|---|
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2108 |
| Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS Pharmacy | 69842-535 |
| Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Wal-Mart Stores Inc | 49035-538 |
| Childrens Walitinloratadine | Loratadine 5 mg/5mL | SolutionOral | Walgreen Company | 0363-2108 |