Over-the-counter drug · ANDA
Crcle Fexofenadine Hydrochloride (Fexofenadine hydrochloride) NDC 57483-230
Fexofenadine hydrochloride 60 mg/1 · Tablet · Oral · Innovus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-230-01 | 5748302300157483023001 | 100 TABLET in 1 CONTAINER (57483-230-01)Marketed from Apr 28, 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)
- Crcle Fexofenadine Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1
- Dosage form
- Tablet
- 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 211075
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 57483-230_f672cd27-4516-4e54-8c4f-8bbdc22dfabdSPL ID f672cd27-4516-4e54-8c4f-8bbdc22dfabdSPL set ID f7784610-7ca5-4489-b391-f2b3f3f6549bRxCUI 997420, 997501UNII 2S068B75ZUUPC 0357483002466, 0357483002459
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N457483023001followed by a unit qualifier and the quantityPackage 57483-0230-01. 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 57483-230
- What is NDC 57483-230?
- 57483-230 is the product NDC for Crcle Fexofenadine Hydrochloride (fexofenadine hydrochloride), Fexofenadine hydrochloride 60 mg/1 tablet, 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?
- Crcle Fexofenadine Hydrochloride (Fexofenadine Hydrochloride).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- 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 Crcle Fexofenadine Hydrochloride?
- 1 other product NDC are listed under this name. See all Crcle Fexofenadine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Crcle Fexofenadine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Crcle Fexofenadine Hydrochloridefexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-240 | 57483-0240-02 |
Other NDCs under ANDA 211075
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 Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Grocery Outlet, Inc. | 85828-192 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TARGET CORPORATION | 11673-767 |
| allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-292 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Bi-Mart | 37835-602 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TOPCO ASSOCIATES LLC | 36800-653 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-292 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Safeway, Inc | 21130-769 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7660 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA Corp | 73581-025 |
| Fexofenadine HCl | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Rite Aid | 11822-7652 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7661 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-026 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7663 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7664 |
| Crcle Fexofenadine Hydrochloridefexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-240 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-095 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS | 51316-767 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS | 51316-768 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Granules India Limited | 62207-623 |
| ValuMeds 24-Hour Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1002 |
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