Over-the-counter drug · ANDA

fexofenadine hcl NDC 50228-202

Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)50228-202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0202Add 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
50228-202-01502280202015022802020130 TABLET, FILM COATED in 1 BOTTLE (50228-202-01)Marketed from Dec 26, 2014
50228-202-0250228020202502280202021000 TABLET, FILM COATED in 1 BOTTLE (50228-202-02)Marketed from Dec 26, 2014
50228-202-03502280202035022802020330 TABLET, FILM COATED in 1 BOTTLE (50228-202-03)Marketed from Dec 26, 2014
50228-202-0450228020204502280202041000 TABLET, FILM COATED in 1 BOTTLE (50228-202-04)Marketed from Dec 26, 2014

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)
fexofenadine hcl
Generic name (nonproprietary)
fexofenadine hcl
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
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 50228-202_2a0b48b8-5955-9ab7-e063-6394a90a6b24SPL ID 2a0b48b8-5955-9ab7-e063-6394a90a6b24SPL set ID b7e9477d-33d9-4463-b8a6-69af5f71ce35RxCUI 997420, 997501UNII 2S068B75ZUUPC 0350228202015, 0350228201032, 0350228202022, 0350228201025, 0350228201018, 0350228202046, 0350228201049, 0350228202039
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

N450228020201 followed by a unit qualifier and the quantity

Package 50228-0202-01. 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 reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-202

What is NDC 50228-202?
50228-202 is the product NDC for fexofenadine hcl, Fexofenadine hydrochloride 180 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
fexofenadine hcl.
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 hcl?
44 other product NDCs are listed under this name. See all fexofenadine hcl 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 hcl NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fexofenadine HCLFexofenadine hydrochloride 60 mg/1TabletOralYYBA Corp73581-01073581-0010-0173581-0010-0673581-0010-10+1 more
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralWalmart Inc.79903-35879903-0358-3079903-0358-4579903-0358-90
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralStrategic Sourcing Services70677-125670677-1256-0170677-1256-02
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-90571610-0905-3071610-0905-5371610-0905-60+1 more
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-20177771-0201-0177771-0201-05
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-20277771-0202-0177771-0202-0577771-0202-30
Fexofenadine HClFexofenadine hydrochloride 60 mg/1TabletOralRite Aid11822-765211822-7652-04
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-766111822-7661-05
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-766311822-7663-04
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-766011822-7660-0311822-7660-0711822-7660-09

All 45 fexofenadine hcl 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
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
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralMagno-Humphries, Inc.54257-170

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