Over-the-counter drug · ANDA
Loratadine Allergy Relief (loratadine) NDC 55289-728
Loratadine 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-728-15 | 55289072815 | 15 TABLET in 1 BOTTLE, PLASTIC (55289-728-15)Marketed from Mar 27, 2021 | |
| 55289-728-20 | 55289072820 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-728-20)Marketed from Mar 27, 2021 | |
| 55289-728-60 | 55289072860 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-728-60)Marketed from Jan 18, 2023 | |
| 55289-728-90 | 55289072890 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-728-90)Marketed from Apr 6, 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 Allergy Relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076134
- Marketing start
- Listing expires
- Identifiers
- Product ID 55289-728_4d61c38c-3562-15bd-e063-6294a90a7adaSPL ID 4d61c38c-3562-15bd-e063-6294a90a7adaSPL set ID 7127b39d-3686-4249-b720-43c02b4c4654RxCUI 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
N455289072815followed by a unit qualifier and the quantityPackage 55289-0728-15. 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.
Other NDCs under ANDA 076134
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 |
|---|---|---|---|---|
| McKesson Loratadineloratadine 10 mg | Loratadine 10 mg/1 | Tablet, Film coatedOral | McKesson Medical Surgical | 68599-4784 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | American Health Packaging | 68084-248 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | DISCOUNT DRUG MART | 53943-975 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | SAFEWAY INC. | 21130-526 |
| Handy Solutions 24 Hour Allergyloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Navajo Manufacturing Company Inc. | 67751-163 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | OHM LABORATORIES INC. | 51660-526 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Premier Value | 68016-526 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-245 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-246 |
| Green Guard 24 Hour Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-118 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Chain Drug Marketing Association Inc. | 63868-151 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-330 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | CVS Pharmacy | 59779-528 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HEB | 37808-529 |
| MEDIQUE Loradamedloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-203 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4976 |
| MEDIQUE Loradamedloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-117 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2387 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7507 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-763 |
Showing 20 of 27.