Over-the-counter drug · ANDA

Terbinafine Hydrochloride NDC 63187-111

Terbinafine hydrochloride 1 g/100g · Cream · Topical · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0111Add 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
63187-111-15631870111151 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBEMarketed from Dec 1, 2018
63187-111-30631870111301 TUBE in 1 CARTON (63187-111-30) / 30 g in 1 TUBEMarketed from Dec 1, 2018

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)
Terbinafine Hydrochloride
Generic name (nonproprietary)
terbinafine hydrochloride
Active ingredients
Terbinafine hydrochloride — 1 g/100g
Dosage form
Cream
Route
Topical
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 63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992SPL ID 96ea8a54-d84e-4ac6-9ce1-2624f20a4992SPL set ID 76f7525d-2005-4da8-a795-50ede6236c68RxCUI 992528UNII 012C11ZU6GUPC 0363187111304
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

N463187011115 followed by a unit qualifier and the quantity

Package 63187-0111-15. 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)

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
Kroger Antifungalterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalKroger Company30142-080
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalScholl's Wellness Company LLC73469-7215
Good Neighbor Pharmacyterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalAmerisourceBergen24385-524
Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalRite Aid Corporation11822-0080
Antifungalterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalMeijer Distribution Inc41250-080
Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalPublix Super Markets Inc.56062-080
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalSun Pharmaceutical Industries, Inc.51672-2080
Cvsterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalCVS Pharmacy59779-523
equate Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalWal-Mart Stores Inc49035-080
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalSun Pharmaceutical Industries, Inc.51672-2140
Good Neighbor Pharmacyterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-4044
Curist Antifungal Reliefterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalLittle Pharma, Inc.72559-035
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
Athletes Footterbinafine hydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalH E B37808-080
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalA-S Medication Solutions50090-1278
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalWALGREEN COMPANY0363-4502
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalPreferred Pharmaceuticals, Inc68788-9814
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalCardinal Health, 110 dba LEADER70000-0338
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalA-S Medication Solutions50090-5810

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