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
Product NDC (as listed)57483-230Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57483-0230Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
57483-230-0157483023001100 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
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

N457483023001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211075

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211075
ProductStrengthForm · routeLabelerProduct NDC
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralCVS PHARMACY, INC51316-801
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSafeway, Inc.21130-451
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralAAA PHARMACEUTICAL, INC.57344-292
Cabinet Allergy Relief Fexofenadinefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCabinet Health P.B.C.82725-3002
Cabinet Allergy Relief Fexofenadinefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCabinet Health P.B.C.82725-3002
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralRETAIL BUSINESS SERVICES , LLC.72476-192
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralCVS51316-767
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralCVS51316-768
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralTARGET CORPORATION11673-767
Crcle Fexofenadine Hydrochloridefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-240
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralWalgreens0363-9760
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralGranules India Limited62207-623
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralHEB37808-392
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralGranules India Ltd62207-765
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralGranules India Ltd62207-766
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralChain Drug Marketing Association, Inc.83324-009
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralGRANULES PHARMACEUTICALS INC.70010-183
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralWalgreens0363-6231
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralGranules India Limited62207-889
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralGranules India Limited62207-891

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Crcle Fexofenadine Hydrochloride NDC 57483-230 | Med-Code