Over-the-counter drug · ANDA
ALLERGY RELIEF 10 mg (Loratadine) NDC 55681-303
Loratadine 10 mg/1 · Tablet · Oral · TWIN MED LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55681-303-03 | 5568103030355681030303 | 300 TABLET in 1 BOTTLE (55681-303-03)Marketed from Mar 2, 2022 |
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)
- ALLERGY RELIEF 10 mgSuffix: 10 mg
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TWIN MED LLCNDC labeler code 55681
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
- Marketing start
- Listing expires
- Identifiers
- Product ID 55681-303_4e68e4e1-8a60-a8f1-e063-6394a90ac63bSPL ID 4e68e4e1-8a60-a8f1-e063-6394a90ac63bSPL set ID d943f548-aa0d-4476-e053-2a95a90a7bd4RxCUI 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
N455681030303followed by a unit qualifier and the quantityPackage 55681-0303-03. 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 sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 55681-303
- What is NDC 55681-303?
- 55681-303 is the product NDC for ALLERGY RELIEF 10 mg (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by TWIN MED LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ALLERGY RELIEF 10 mg (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- TWIN MED LLC, NDC labeler code 55681. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ALLERGY RELIEF 10 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Medi-First Plus Allery Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-912 |
| 24 / 7 Life Non-Drowsy Allergy Reliefloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 29485-8156 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2431 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8659 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | GRANULES USA, INC. | 69848-019 |
| Allergy Reliefloratadine 10mg | Loratadine 10 mg/1 | TabletOral | First Aid Direct | 53117-414 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | AMERIFOODS TRADING COMPANY | 61504-193 |
| CAREALL Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | New World Imports | 51824-103 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HARRIS TEETER | 72036-193 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | FSA STORE INC. | 81522-393 |
| First Aid Direct Allergy Reliefloratadine tablets | Loratadine 10 mg/1 | TabletOral | Cintas Corporation | 42961-120 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Camber Consumer Care Inc | 69230-328 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-493 |
| Curist Allergy Reliefloratadine 10 mg | Loratadine 10 mg/1 | TabletOral | Little Pharma, Inc. | 72559-033 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AMZ789 LLC | 73629-003 |
| Loratadine 10mg | Loratadine 10 mg/1 | TabletOral | Meijer | 79481-7870 |
| Dr Simi All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-201 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-9787 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2529 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-193 |
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