Over-the-counter drug · ANDA
CounterAct Allergy (Loratadine) NDC 54473-166
Loratadine 10 mg/1 · Tablet · Oral · Melaleuca, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-166-32 | 5447301663254473016632 | 1 BOTTLE in 1 BOX (54473-166-32) / 30 TABLET in 1 BOTTLEMarketed from Feb 28, 2025 |
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)
- CounterAct AllergySuffix: Allergy
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Melaleuca, Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075209
- Marketing start
- Listing expires
- Identifiers
- Product ID 54473-166_308f1711-b64c-1708-e063-6294a90ad99bSPL ID 308f1711-b64c-1708-e063-6294a90ad99bSPL set ID 6b5d43ad-a709-4e0b-b91c-36ea0afe7221RxCUI 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
N454473016632followed by a unit qualifier and the quantityPackage 54473-0166-32. 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)
Use 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 54473-166
- What is NDC 54473-166?
- 54473-166 is the product NDC for CounterAct Allergy (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Melaleuca, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CounterAct Allergy (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Melaleuca, Inc., NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CounterAct Allergy?
- 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 075209
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 |
|---|---|---|---|---|
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Safeway, Inc. | 21130-914 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-938 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-718 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-985 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-156 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-437 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-146 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-147 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6164 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-658 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-350 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4016 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2181 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-150 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0007 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0800 |
| Claritinloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-9742 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Select Consumer Group | 85237-1630 |
| Indoor Outdoor Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-0858 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0753 |
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