Over-the-counter drug · ANDA
Crcle Cetirizine Hydrochloride (Cetirizine hydrochloride) NDC 57483-250
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Innovus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-250-01 | 5748302500157483025001 | 365 TABLET in 1 CONTAINER (57483-250-01)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 Cetirizine Hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 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 209274
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 57483-250_b1644d9c-353b-44bf-b3f9-9bd8b83976f2SPL ID b1644d9c-353b-44bf-b3f9-9bd8b83976f2SPL set ID 640583b6-379d-4ad3-b00c-383377c54eedRxCUI 1014678UNII 64O047KTOA
- 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
N457483025001followed by a unit qualifier and the quantityPackage 57483-0250-01. 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 57483-250
- What is NDC 57483-250?
- 57483-250 is the product NDC for Crcle Cetirizine Hydrochloride (cetirizine hydrochloride), Cetirizine hydrochloride 10 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 Cetirizine Hydrochloride (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine 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 Cetirizine Hydrochloride?
- 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 209274
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 Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc | 85828-194 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | AAA PHARMACEUTICAL, INC. | 57344-194 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Bi-Mar | 37835-611 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-0057 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | LIDL US LLC | 71141-294 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-091 |
| Cetirizinecetiirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-764 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Advanced Rx LLC | 80513-731 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules Pharmaceuticals Inc. | 70010-163 |
| ValuMeds 24-Hour Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1003 |
| CABINET Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0119 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9733 |
| ValuMeds Cetirizine 10mgcetirizine 10mg | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health | 82725-1203 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-806 |
| Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | YYBA CORP | 73581-202 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules India Ltd | 62207-764 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4230 |
| Allergy Relief | Cetirizine hydrochloride 10 mg/1 | TabletOral | Demoulas Super Markets, Inc. | 53942-396 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4219 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1047 |
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