Over-the-counter drug · ANDA
Loratadine antihistamine (loratadine) NDC 43353-259
Loratadine 10 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-259-09 | 43353025909 | 9000 TABLET in 1 BOTTLE (43353-259-09)Marketed from Sep 8, 2022 | |
| 43353-259-18 | 43353025918 | 3000 TABLET in 1 BOTTLE (43353-259-18)Marketed from Oct 17, 2022 | |
| 43353-259-60 | 43353025960 | 90 TABLET in 1 BOTTLE (43353-259-60)Marketed from Nov 23, 2016 |
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 antihistamineSuffix: antihistamine
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 43353-259_15aaaeb4-fda5-f5e2-e063-6394a90a47eeSPL ID 15aaaeb4-fda5-f5e2-e063-6394a90a47eeSPL set ID a2c92766-df4e-4414-9c42-e18bcf9db6b4RxCUI 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
N443353025909followed by a unit qualifier and the quantityPackage 43353-0259-09. 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.
Other NDCs under ANDA 076301
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 | A-S Medication Solutions | 50090-7066 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-1612 |
| basic care allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Amazon.com Services LLC | 72288-612 |
| foster and thrive allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1022 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7049 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-0612 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7048 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7051 |
| CareOne Allergy Relief 24 Hourloratadine | Loratadine 10 mg/1 | TabletOral | American Sales Company | 41520-612 |
| equate allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-612 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HyVee Inc | 42507-612 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6852 |
| kirkland signature allerclearloratadine | Loratadine 10 mg/1 | TabletOral | Costco Wholesale Company | 63981-612 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-347 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0836 |
| TopCare Allergy Relief 24 hourloratadine | Loratadine 10 mg/1 | TabletOral | Topco Associates LLC | 36800-612 |
| goodnow allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Gobrands, Inc | 82501-0612 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5532 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7158 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0188 |
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