Over-the-counter drug · ANDA

Terbinafine Hydrochloride NDC 70000-0338

Terbinafine hydrochloride 1 g/100g · Cream · Topical · Cardinal Health, 110 dba LEADER

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0338Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0338Add 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
70000-0338-1700000338011 TUBE in 1 CARTON (70000-0338-1) / 15 g in 1 TUBEMarketed from Jul 30, 2018

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)
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 70000-0338_39854f19-d8c0-6438-e063-6394a90a9422SPL ID 39854f19-d8c0-6438-e063-6394a90a9422SPL set ID a9412747-c7f9-4242-91ed-3695f372f6c9RxCUI 992528UNII 012C11ZU6G
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

N470000033801 followed by a unit qualifier and the quantity

Package 70000-0338-01. 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)

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/100gCreamTopicalProficient Rx LP63187-111
Terbinafine HydrochlorideTerbinafine hydrochloride 1 g/100gCreamTopicalA-S Medication Solutions50090-5810

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

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in