Over-the-counter drug · ANDA

Cvs (Terbinafine hydrochloride) NDC 59779-523

Terbinafine hydrochloride 1 g/100g · Cream · Topical · CVS Pharmacy

NDC codes

FDA NDC Directory
Product NDC (as listed)59779-523Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59779-0523Add 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
59779-523-0159779052301597790523011 TUBE in 1 CARTON (59779-523-01) / 15 g in 1 TUBEMarketed from Dec 9, 2008

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)
Cvs
Generic name (nonproprietary)
terbinafine hydrochloride
Active ingredients
Terbinafine hydrochloride — 1 g/100g
Dosage form
Cream
Route
Topical
Labeler
CVS PharmacyNDC labeler code 59779
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 59779-523_446e5c7a-48c9-cef4-e063-6294a90a6d32SPL ID 446e5c7a-48c9-cef4-e063-6294a90a6d32SPL set ID 17684ba2-3c2c-4259-84fa-3833f19e5a4dRxCUI 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

N459779052301 followed by a unit qualifier and the quantity

Package 59779-0523-01. 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 jock itch (tinea cruris) relieves itching, burning, cracking and scaling which accompanies this condition

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59779-523

What is NDC 59779-523?
59779-523 is the product NDC for Cvs (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cvs (Terbinafine Hydrochloride).
What is the active ingredient?
Terbinafine hydrochloride.
Who is the labeler?
CVS Pharmacy, NDC labeler code 59779. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cvs?
5 other product NDCs are listed under this name. See all Cvs 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 Cvs NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CvspetrolatumPetrolatum 41 g/100gOintmentTopicalApollo Health and Beauty Care63148-17863148-0178-14
Cvschildrens stuffy nose and coldGuaifenesin 100 mg/5mL; Phenylephrine hydrochloride 2.5 mg/5mLSolutionOralCVS PHARMACY, INC69842-48769842-0487-04
Cvssodium chloride, sodium bicarbonate—KitCVS Pharmacy, Inc.69842-45369842-0453-10
Cvssodium chloride, sodium bicarbonate—KitCVS Pharmacy, Inc.69842-34969842-0349-10
Cvssodium bicarbonate, sodium chlorideSodium bicarbonate 22.8 mg/100mg; Sodium chloride 77.8 mg/100mgPowderNasalCVS Pharmacy59779-40859779-0408-0159779-0408-02

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
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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