Over-the-counter drug · ANDA

Fexofenadine hydrochloride NDC 55111-783

Fexofenadine hydrochloride 60 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)55111-783Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0783Add 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
55111-783-0155111078301100 TABLET in 1 BOTTLE (55111-783-01)Marketed from Jan 3, 2011
55111-783-24551110783244 BLISTER PACK in 1 CARTON (55111-783-24) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020
55111-783-28551110783282 BLISTER PACK in 1 CARTON (55111-783-28) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020
55111-783-605511107836060 TABLET in 1 BOTTLE (55111-783-60)Marketed from Jan 3, 2011
55111-783-785511107837810 BLISTER PACK in 1 CARTON (55111-783-78) / 10 TABLET in 1 BLISTER PACK (55111-783-79)Marketed from Jan 3, 2011
55111-783-905511107839090 TABLET in 1 BOTTLE (55111-783-90)Marketed from Jan 3, 2011

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 hydrochloride
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 60 mg/1
Dosage form
Tablet
Route
Oral
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 55111-783_c5d24cd6-8212-e647-78b1-27906e6f62bdSPL ID c5d24cd6-8212-e647-78b1-27906e6f62bdSPL set ID 864e3052-5787-bf11-9d17-11274ca2304fRxCUI 997420, 997488, 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

N455111078301 followed by a unit qualifier and the quantity

Package 55111-0783-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralChain Drug Marketing Associate63868-025
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDr. Reddy's Laboratories Limited55111-784
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralDr. Reddy's Laboratories Inc.43598-936
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralRite Aid Corporation11822-3698
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralKROGER COMPANY30142-878
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralWalgreens Company0363-0783
Wal-Fexfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralWalgreens Company0363-0784
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralChain Drug Consortium, LLC68016-995
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSafeway Inc21130-784
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralFamily Dollar Stores, Inc.55319-917
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCVS Health Corp.69842-052
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDollar General55910-111
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSam's West Inc.68196-107
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDr. Reddy's Laboratories Inc.43598-809
Non-Drowsy Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralTARGET CORPORATION11673-621
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralBluePoint Laboratories68001-439
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralBluePoint Laboratories68001-440
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralStrategic Sourcing Services, LLC70677-1009
Fexofenadine hydrochlorideFexofenadine hydrochloride 30 mg/1TabletOralDr. Reddy's Laboratories Limited55111-782

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