Over-the-counter drug · ANDA

Fexofenadine Hydrochloride (Fexofenadine hcl) NDC 0904-7050

Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7050Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7050Add 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
0904-7050-400090470504000904705040500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40)Marketed from Nov 29, 2019
0904-7050-600090470506000904705060100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60)Marketed from Nov 29, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Fexofenadine Hydrochloride
Generic name (nonproprietary)
fexofenadine hcl
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204507
Marketing start
Marketing end
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0904-7050_33be2075-3e84-4738-af91-6f2f971cc0b4SPL ID 33be2075-3e84-4738-af91-6f2f971cc0b4SPL set ID c34cda59-8a63-48ab-a19d-c06a1878f5daRxCUI 997420UNII 2S068B75ZUUPC 0309047050406
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

N400904705040 followed by a unit qualifier and the quantity

Package 00904-7050-40. 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)

About NDC 0904-7050

What is NDC 0904-7050?
0904-7050 is the product NDC for Fexofenadine Hydrochloride (fexofenadine hcl), Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fexofenadine Hydrochloride (Fexofenadine HCl).
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fexofenadine Hydrochloride?
42 other product NDCs are listed under this name. See all Fexofenadine Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fexofenadine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fexofenadine Hydrochloridefexofenadine hydrochloride oralFexofenadine hydrochloride 30 mg/5mLSuspensionOralAurohealth LLC58602-42758602-0427-2058602-0427-24
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralNUVICARE LLC84324-04584324-0045-01
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA Corp73581-02573581-0025-0173581-0025-0673581-0025-20
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-02673581-0026-0173581-0026-1073581-0026-20
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-02773581-0027-0173581-0027-0473581-0027-10+1 more
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAMZ789 LLC73629-00873629-0008-03
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-00884324-0008-01
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAMERISOURCE BERGEN46122-77946122-0779-5846122-0779-6146122-0779-66
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralPioneer Life Sciences, LLC72090-01072090-0010-01
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralGranules India Limited62207-88962207-0889-4962207-0889-5162207-0889-60

All 43 Fexofenadine Hydrochloride NDCs

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
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA CORP73581-011
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralBi-Mart37835-601
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-201
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-202
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA CORP73581-103
Fexofenadine HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAdvanced Rx LLC80513-506
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralSPIRIT PHARMACEUTICALS LLC68210-4090
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralSPIRIT PHARMACEUTICALS LLC68210-2210
Allergy Relief non drowsyfexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralMEIJER, INC.41250-506
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Capsule, CoatedOralAllegiant Health69168-416
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, Inc.50228-201
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, Inc.50228-202
IAllergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralSafeway, Inc.21130-405
Gencare-Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralPioneer Life Sciences, LLC72090-068
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2165
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralNUVICARE LLC84324-045
Fexofenadine HClFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralCamber Consumer Care69230-201
Fexofenadine HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCamber Consumer Care69230-202
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralP & L Development, LLC59726-701
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7192

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