Over-the-counter drug · ANDA
Loratadine NDC 48433-064
Loratadine 10 mg/1 · Tablet · Oral · Safecor Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-064-20 | 48433006420 | 100 BLISTER PACK in 1 CARTON (48433-064-20) / 1 TABLET in 1 BLISTER PACK (48433-064-01)Marketed from Mar 24, 2026 |
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
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Safecor Health, LLCNDC labeler code 48433
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076154
- Marketing start
- Listing expires
- Identifiers
- Product ID 48433-064_4e5410fd-6d27-f0d2-e063-6394a90a016fSPL ID 4e5410fd-6d27-f0d2-e063-6394a90a016fSPL set ID 14d1ecf5-d694-4ce0-87e4-df27f3f4d909RxCUI 311372UNII 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
N448433006420followed by a unit qualifier and the quantityPackage 48433-0064-20. 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 48433-064
- What is NDC 48433-064?
- 48433-064 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Safecor Health, LLC. 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?
- Safecor Health, LLC, NDC labeler code 48433. 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 | 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 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc | 68788-8616 | 68788-8616-0068788-8616-0168788-8616-03+3 more |
Other NDCs under ANDA 076154
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 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-8880 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-246 |