Over-the-counter drug · ANDA

Allergy Relief (fexofenadine hcl) NDC 69168-416

Fexofenadine hydrochloride 180 mg/1 · Capsule, Coated · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-416Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0416Add 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
69168-416-03691680416033 CAPSULE, COATED in 1 CARTON (69168-416-03)Marketed from Aug 14, 2020
69168-416-0669168041606120 CAPSULE, COATED in 1 BOTTLE, PLASTIC (69168-416-06)Marketed from Aug 14, 2020
69168-416-306916804163030 CAPSULE, COATED in 1 BOTTLE (69168-416-30)Marketed from Aug 14, 2020

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)
Allergy Relief
Generic name (nonproprietary)
fexofenadine hcl
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Capsule, Coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204507
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69168-416_054a111e-78f9-453f-8ee2-c54d64c116e4SPL ID 054a111e-78f9-453f-8ee2-c54d64c116e4SPL set ID 61eebc8a-8d1e-48a2-afb1-eda9cb00ff97UNII 2S068B75ZU
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

N469168041603 followed by a unit qualifier and the quantity

Package 69168-0416-03. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204507

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

FDA NDC Directory listings under ANDA 204507
ProductStrengthForm · routeLabelerProduct NDC
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralSPIRIT PHARMACEUTICALS LLC68210-2210
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralSPIRIT PHARMACEUTICALS LLC68210-4090
Fexofenadine HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAdvanced Rx LLC80513-506
Gencare-Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralPioneer Life Sciences, LLC72090-068
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, Inc.50228-202
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, Inc.50228-201
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2165
Curist Allergy Relieffexofenadine hydrochloride 180 mgFexofenadine hydrochloride 180 mg/1TabletOralLittle Pharma, Inc.72559-027
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralBi-Mart37835-601
Curist Hives Relieffexofenadine hydrochloride 180 mgFexofenadine hydrochloride 180 mg/1TabletOralLittle Pharma, Inc.72559-028
Fexofenadine Hydrochloridefexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralNorthwind Health Company, LLC51655-231
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralAkron Pharma Inc.71399-8042
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralAKRON PHARMA INC71399-8659
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-893
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-905
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA CORP73581-011
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralMagno-Humphries, Inc.54257-170
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA CORP73581-103
Fexofenadine HClFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralCamber Consumer Care69230-201
Fexofenadine HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCamber Consumer Care69230-202

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