Over-the-counter drug · ANDA
Allervarx (Loratadine) NDC 57483-955
Loratadine 5 mg/1 · Tablet, Orally disintegrating · Oral · Innovus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-955-05 | 5748309550557483095505 | 3 BLISTER PACK in 1 CARTON (57483-955-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 1, 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)
- Allervarx
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Innovus Pharmaceuticals, Inc.NDC labeler code 57483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212795
- Marketing start
- Listing expires
- Identifiers
- Product ID 57483-955_a0d195de-77a2-4627-bcaf-6fa13549882cSPL ID a0d195de-77a2-4627-bcaf-6fa13549882cSPL set ID ec4d1e77-6995-4228-8e63-a9ab6232daceRxCUI 672558UNII 7AJO3BO7QNUPC 0357483002312
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
N457483095505followed by a unit qualifier and the quantityPackage 57483-0955-05. 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 57483-955
- What is NDC 57483-955?
- 57483-955 is the product NDC for Allervarx (loratadine), Loratadine 5 mg/1 tablet, orally disintegrating, listed with the FDA by Innovus Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allervarx (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Innovus Pharmaceuticals, Inc., NDC labeler code 57483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allervarx?
- 1 other product NDC are listed under this name. See all Allervarx NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allervarx products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allervarxloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Innovus Pharmaceuticals, Inc. | 57483-950 | 57483-0950-10 |
Other NDCs under ANDA 212795
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 5 mg/1 | TabletOral | Walgreens Company | 0363-9955 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 43598-756 |
| Loratadine | Loratadine 5 mg/1 | Tablet, Orally disintegratingOral | CVS PHARMACY, INC | 51316-502 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Strides Pharma Inc | 59556-301 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Tenshi Kaizen Pvt Ltd | 72983-500 |