Over-the-counter drug · ANDA
Medique Loradamed (Loratadine) NDC 47682-403
Loratadine 10 mg/1 · Tablet · Oral · Unifirst First Aid Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47682-403-12 | 4768204031247682040312 | 10 PACKET in 1 BOX (47682-403-12) / 1 TABLET in 1 PACKETMarketed from Jun 1, 2023 | |
| 47682-403-46 | 4768204034647682040346 | 1 TABLET in 1 PACKET (47682-403-46)Marketed from Jun 1, 2023 | |
| 47682-403-50 | 4768204035047682040350 | 50 PACKET in 1 BOX (47682-403-50) / 1 TABLET in 1 PACKETMarketed from Jun 1, 2023 |
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)
- Medique Loradamed
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Unifirst First Aid CorporationNDC labeler code 47682
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
- Marketing start
- Listing expires
- Identifiers
- Product ID 47682-403_441b212c-1a4f-5b61-e063-6294a90a63fdSPL ID 441b212c-1a4f-5b61-e063-6294a90a63fdSPL set ID f98a45fd-cda8-4884-e053-6294a90a57b5RxCUI 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
N447682040312followed by a unit qualifier and the quantityPackage 47682-0403-12. 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 repiratory allergies runny nose itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 47682-403
- What is NDC 47682-403?
- 47682-403 is the product NDC for Medique Loradamed (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Unifirst First Aid Corporation. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Medique Loradamed (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Unifirst First Aid Corporation, NDC labeler code 47682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Medique Loradamed?
- 2 other product NDCs are listed under this name. See all Medique Loradamed NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Medique Loradamed products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| MEDIQUE Loradamedloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-203 | 47682-0203-1247682-0203-4647682-0203-50 |
| MEDIQUE Loradamedloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-117 | 85766-0117-1285766-0117-4685766-0117-50 |
Other NDCs under ANDA 210722
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 |
|---|---|---|---|---|
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Grocery Outlet, Inc | 85828-193 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2529 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-193 |
| Green Guard 24 Hour Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-117 |
| XL - 3 Allergy | Loratadine 10 mg/1 | TabletOral | Selder, S.A. de C.V. | 63654-415 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bi-Mart | 37835-621 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3596 |
| McKesson Loradatineloratainde | Loratadine 10 mg/1 | TabletOral | McKesson Medical Surgical | 68599-4785 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Safeway, Inc | 21130-780 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Advanced Rx LLC | 80513-711 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-162 |
| ValuMeds Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1042 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Spirit Pharmaceuticals LLC | 68210-4110 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Granules India Limited | 62207-787 |
| LORATADINE ALLERGY RELIEF 10mgloratadine | Loratadine 10 mg/1 | TabletOral | YYBA CORP | 73581-230 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Allegiant Health | 69168-414 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Valu Merchandisers Company | 63941-193 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-831 |
| Non-Drowsy Allergy Relief, 24-7 Lifeloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-6551 |
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