Over-the-counter drug · ANDA

Athletes Foot (Terbinafine hydrochloride) NDC 11822-0080

Terbinafine hydrochloride 1 g/100g · Cream · Topical · Rite Aid Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)11822-0080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-0080Add 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
11822-0080-111822008001118220080011 TUBE in 1 CARTON (11822-0080-1) / 15 g in 1 TUBEMarketed from Oct 28, 2019
11822-0080-211822008002118220080021 TUBE in 1 CARTON (11822-0080-2) / 30 g in 1 TUBEMarketed from Oct 28, 2019

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)
Athletes Foot
Generic name (nonproprietary)
terbinafine hydrochloride
Active ingredients
Terbinafine hydrochloride — 1 g/100g
Dosage form
Cream
Route
Topical
Labeler
Rite Aid CorporationNDC labeler code 11822
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077511
Marketing start
Listing expires
Other FDA classes
Allylamine (Chemical structure)
Identifiers
Product ID 11822-0080_3b03975b-5aeb-8ee4-e063-6394a90a12bcSPL ID 3b03975b-5aeb-8ee4-e063-6394a90a12bcSPL set ID a7b0a70b-a117-48cf-a6bc-260be1dac1e7RxCUI 992528UNII 012C11ZU6GUPC 0011822290043
Pharmacologic class
Allylamine Antifungal

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N411822008001 followed by a unit qualifier and the quantity

Package 11822-0080-01. 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 cures most athlete's foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11822-0080

What is NDC 11822-0080?
11822-0080 is the product NDC for Athletes Foot (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Rite Aid Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Athletes Foot (Terbinafine Hydrochloride).
What is the active ingredient?
Terbinafine hydrochloride.
Who is the labeler?
Rite Aid Corporation, NDC labeler code 11822. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Athletes Foot?
15 other product NDCs are listed under this name. See all Athletes Foot 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 Athletes Foot NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Athletes Footmiconazole nitrateMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc56104-91256104-0912-01
Athletes FoottolnaftateTolnaftate 10 mg/gAerosol, SprayTopicalRugby Laboratories0536-148100536-1481-01
Athletes Footmiconazole nitrateMiconazole nitrate 2 g/100mLCreamTopicalRida LLC83004-01483004-0014-01
Athletes Footbutenafine hydrochlorideButenafine hydrochloride 10 mg/gCreamTopicalSTRATEGIC SOURCING SERVICES LLC70677-126970677-1269-01
Athletes FoottolnaftateTolnaftate 1 g/100mLSolution/ dropsTopicalImperial Feet B.V.83837-00283837-0002-01
Athletes FootclotrimazoleClotrimazole 10 mg/gCreamTopicalFRED'S, INC.55315-00855315-0008-56
Athletes Footbutenafine hydrochlorideButenafine hydrochloride 10 mg/gCreamTopicalWalgreen Company0363-210000363-2100-02
Athletes Footbutenafine hydrochlorideButenafine hydrochloride 10 mg/gCreamTopicalTarget Corporation11673-01611673-0016-02
Athletes Footbutenafine hydrochlorideButenafine hydrochloride 10 mg/gCreamTopicalRite Aid Corporation11822-210011822-2100-0211822-2100-08
Athletes Footbutenafine hydrochlorideButenafine hydrochloride 10 mg/gCreamTopicalTOPCO ASSOCIATES LLC36800-04936800-0049-01

All 16 Athletes Foot NDCs

Other NDCs under ANDA 077511

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

FDA NDC Directory listings under ANDA 077511
ProductStrengthForm · routeLabelerProduct NDC
Antifungalterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalMeijer Distribution Inc41250-080
Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalH E B37808-080
Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalPublix Super Markets Inc.56062-080
Curist Antifungal Reliefterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalLittle Pharma, Inc.72559-035
Cvsterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalCVS Pharmacy59779-523
CVS Pharmacy Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalCVS Pharmacy59779-080
equate Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalWal-Mart Stores Inc49035-080
Good Neighbor Pharmacyterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalAmerisourceBergen24385-524
Good Neighbor Pharmacyterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-4044
Kroger Antifungalterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalKroger Company30142-080
Silka Antifungalterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalGenomma Lab USA, Inc.50066-080
Silka Jock Itchterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalGenomma Lab USA, Inc.50066-208
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalWALGREEN COMPANY0363-4502
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalA-S Medication Solutions50090-1278
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalA-S Medication Solutions50090-5810
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalSun Pharmaceutical Industries, Inc.51672-2080
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalSun Pharmaceutical Industries, Inc.51672-2140
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalProficient Rx LP63187-111
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalPreferred Pharmaceuticals, Inc68788-9814
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalCardinal Health, 110 dba LEADER70000-0338

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