Over-the-counter drug · ANDA

Wal-Fex (Fexofenadine hydrochloride) NDC 0363-0784

Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · Walgreens Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0784Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0784Add 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
0363-0784-0700363078407003630784071 BLISTER PACK in 1 CARTON (0363-0784-07) / 5 TABLET in 1 BLISTER PACKMarketed from Apr 13, 2011
0363-0784-1500363078415003630784151 BOTTLE in 1 CARTON (0363-0784-15) / 150 TABLET in 1 BOTTLEMarketed from Apr 13, 2011
0363-0784-180036307841800363078418180 TABLET in 1 BOTTLE (0363-0784-18)Marketed from Jul 13, 2022
0363-0784-2900363078429003630784293 BLISTER PACK in 1 CARTON (0363-0784-29) / 5 TABLET in 1 BLISTER PACKMarketed from Apr 13, 2011
0363-0784-3000363078430003630784301 BOTTLE in 1 CARTON (0363-0784-30) / 30 TABLET in 1 BOTTLEMarketed from Apr 13, 2011
0363-0784-4000363078440003630784401 BOTTLE in 1 CARTON (0363-0784-40) / 40 TABLET in 1 BOTTLEMarketed from Apr 13, 2011
0363-0784-4300363078443003630784432 BOTTLE in 1 CARTON (0363-0784-43) / 30 TABLET in 1 BOTTLEMarketed from Apr 13, 2011
0363-0784-4500363078445003630784451 BOTTLE in 1 CARTON (0363-0784-45) / 45 TABLET in 1 BOTTLEMarketed from Apr 13, 2011
0363-0784-7500363078475003630784751 BOTTLE in 1 CARTON (0363-0784-75) / 70 TABLET in 1 BOTTLEMarketed from Apr 13, 2011
0363-0784-9000363078490003630784901 BOTTLE in 1 CARTON (0363-0784-90) / 90 TABLET in 1 BOTTLEMarketed from Apr 13, 2011

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)
Wal-Fex
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Walgreens CompanyNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076502
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0363-0784_7e7ffc3e-e6f3-18ec-ed27-f9268790597eSPL ID 7e7ffc3e-e6f3-18ec-ed27-f9268790597eSPL set ID 95d420ea-6337-304f-54c3-0c75be1608e2RxCUI 997420, 1116528UNII 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

N400363078407 followed by a unit qualifier and the quantity

Package 00363-0784-07. 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)

Use(s) 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 0363-0784

What is NDC 0363-0784?
0363-0784 is the product NDC for Wal-Fex (fexofenadine hydrochloride), Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by Walgreens Company. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Wal-Fex (Fexofenadine hydrochloride).
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
Walgreens Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Wal-Fex?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 076502

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

FDA NDC Directory listings under ANDA 076502
ProductStrengthForm · routeLabelerProduct NDC
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralRite Aid Corporation11822-3698
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSafeway Inc21130-784
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralFamily Dollar Stores, Inc.55319-917
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralWalgreens Company0363-0783
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralKROGER COMPANY30142-878
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDr. Reddy's Laboratories Inc.43598-809
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralDr. Reddy's Laboratories Inc.43598-936
Fexofenadine hydrochlorideFexofenadine hydrochloride 30 mg/1TabletOralDr. Reddy's Laboratories Limited55111-782
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralDr. Reddy's Laboratories Limited55111-783
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDr. Reddy's Laboratories Limited55111-784
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDollar General55910-111
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralChain Drug Marketing Associate63868-025
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralBluePoint Laboratories68001-439
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralBluePoint Laboratories68001-440
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralChain Drug Consortium, LLC68016-995
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSam's West Inc.68196-107
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCVS Health Corp.69842-052
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralStrategic Sourcing Services, LLC70677-1009
Non-Drowsy Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralTARGET CORPORATION11673-621

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