Over-the-counter drug · ANDA
Loratadine antihistamine (Loratadine) NDC 72789-380
Loratadine 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-380-15 | 72789038015 | 15 TABLET in 1 BOTTLE, PLASTIC (72789-380-15)Marketed from Feb 7, 2024 |
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
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 72789-380_4bc0370f-21d9-1acb-e063-6394a90ad768SPL ID 4bc0370f-21d9-1acb-e063-6394a90ad768SPL set ID 775885f9-0580-4eca-94d8-44fce1dcdccdRxCUI 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
N472789038015followed by a unit qualifier and the quantityPackage 72789-0380-15. 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 72789-380
- What is NDC 72789-380?
- 72789-380 is the product NDC for Loratadine antihistamine (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine antihistamine (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 antihistamine?
- 8 other product NDCs are listed under this name. See all Loratadine antihistamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loratadine antihistamine 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 antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8217 | 00615-8217-3000615-8217-39 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Padagis Israel Pharmaceuticals Ltd | 45802-650 | 45802-0650-6545802-0650-7545802-0650-78+1 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-601 | 63187-0601-1063187-0601-1463187-0601-30+2 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-653 | 66267-0653-0766267-0653-1066267-0653-14+4 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0836 | 50090-0836-0050090-0836-0450090-0836-05 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-259 | 43353-0259-0943353-0259-1843353-0259-60 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-347 | 72789-0347-1472789-0347-2072789-0347-30+2 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3414 | 68071-3414-03 |
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 | Major Pharmaceuticals | 0904-6852 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8217 |
| Berkley and Jensen Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | BJWC | 68391-314 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-423 |
| up and up allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Target Corporation | 11673-612 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Padagis Israel Pharmaceuticals Ltd | 45802-650 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Kroger Company | 30142-612 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Meijer Distribution Inc | 41250-612 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-601 |
| members mark allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Sam's West Inc | 68196-711 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-653 |
| good neighbor pharmacy loratadineloratadine | Loratadine 10 mg/1 | TabletOral | Amerisource Bergen | 24385-471 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-0612 |
| foster and thrive allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1022 |
| basic care allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Amazon.com Services LLC | 72288-612 |
| goodnow allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Gobrands, Inc | 82501-0612 |
| 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 | 50090-7049 |
| 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 |
Showing 20 of 39.