Over-the-counter drug · ANDA

fexofenadine hcl NDC 71335-2165

Fexofenadine hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2165Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2165Add 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
71335-2165-1713352165017133521650130 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1)Marketed from Sep 6, 2024
71335-2165-2713352165027133521650210 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2)Marketed from Aug 25, 2022
71335-2165-3713352165037133521650360 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3)Marketed from Sep 6, 2024
71335-2165-4713352165047133521650490 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4)Marketed from Sep 6, 2024
71335-2165-5713352165057133521650514 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5)Marketed from Sep 6, 2024
71335-2165-6713352165067133521650620 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6)Marketed from Sep 6, 2024
71335-2165-7713352165077133521650712 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7)Marketed from Nov 8, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 60 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-2165_04a27808-de0a-4100-9aff-3168e4fd231eSPL ID 04a27808-de0a-4100-9aff-3168e4fd231eSPL set ID c23ad304-a5de-454e-a135-4eb143af2381RxCUI 997501UNII 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

N471335216501 followed by a unit qualifier and the quantity

Package 71335-2165-01. 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)

About NDC 71335-2165

What is NDC 71335-2165?
71335-2165 is the product NDC for fexofenadine hcl, Fexofenadine hydrochloride 60 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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?
45 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 180 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-20277771-0202-0177771-0202-0577771-0202-30
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-20177771-0201-0177771-0201-05
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-766111822-7661-05
Fexofenadine HClFexofenadine hydrochloride 60 mg/1TabletOralRite Aid11822-765211822-7652-04
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 46 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
IAllergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralSafeway, Inc.21130-405
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralP & L Development, LLC59726-701
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-893
Curist Allergy Relieffexofenadine hydrochloride 180 mgFexofenadine hydrochloride 180 mg/1TabletOralLittle Pharma, Inc.72559-027
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralMagno-Humphries, Inc.54257-170
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralAkron Pharma Inc.71399-8042
Curist Hives Relieffexofenadine hydrochloride 180 mgFexofenadine hydrochloride 180 mg/1TabletOralLittle Pharma, Inc.72559-028
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralP & L Development, LLC59726-801
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralNUVICARE LLC84324-045
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralAKRON PHARMA INC71399-8659
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-905
Fexofenadine HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralProficient Rx LP63187-921
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA CORP73581-011
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralBi-Mart37835-601
Fexofenadine HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCamber Consumer Care69230-202
Fexofenadine HClFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralCamber Consumer Care69230-201
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA CORP73581-103
fexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7192
fexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralRadha Pharmaceuticals77771-202
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralSPIRIT PHARMACEUTICALS LLC68210-2210

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