Over-the-counter drug · ANDA

Silka Antifungal (Terbinafine hydrochloride) NDC 50066-080

Terbinafine hydrochloride 1 g/100g · Cream · Topical · Genomma Lab USA, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)50066-080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50066-0080Add 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
50066-080-0250066008002500660080021 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBEMarketed from Jul 2, 2007
50066-080-0350066008003500660080031 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBEMarketed from May 21, 2018
50066-080-0550066008005500660080051 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBEMarketed from Dec 20, 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)
Silka AntifungalSuffix: Antifungal
Generic name (nonproprietary)
terbinafine hydrochloride
Active ingredients
Terbinafine hydrochloride — 1 g/100g
Dosage form
Cream
Route
Topical
Labeler
Genomma Lab USA, Inc.NDC labeler code 50066
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 50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3aSPL ID 38f62b9e-4081-44e8-e063-6394a90a1f3aSPL set ID a32cf699-e63e-4bd3-a5af-9e1ba447e02eRxCUI 992528, 1739221UNII 012C11ZU6GUPC 0650066000485
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

N450066008002 followed by a unit qualifier and the quantity

Package 50066-0080-02. 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 50066-080

What is NDC 50066-080?
50066-080 is the product NDC for Silka Antifungal (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Genomma Lab USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Silka Antifungal (Terbinafine Hydrochloride).
What is the active ingredient?
Terbinafine hydrochloride.
Who is the labeler?
Genomma Lab USA, Inc., NDC labeler code 50066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Silka Antifungal?
1 other product NDC are listed under this name. See all Silka Antifungal 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 Silka Antifungal NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Silka AntifungaltolnaftateTolnaftate 1 g/100mLLiquidTopicalGenomma Lab USA50066-08550066-0085-01

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/100gCreamTopicalRite Aid Corporation11822-0080
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 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

Showing 20 of 23.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in