NDC codes

FDA NDC Directory
Product NDC (as listed)62135-572Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0572Add 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
62135-572-306213505723030 TABLET in 1 BOTTLE (62135-572-30)Marketed from Mar 8, 2022
62135-572-906213505729090 TABLET in 1 BOTTLE (62135-572-90)Marketed from Mar 8, 2022

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
Generic name (nonproprietary)
terbinafine
Active ingredients
Terbinafine hydrochloride — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078199
Marketing start
Listing expires
Other FDA classes
Allylamine (Chemical structure)
Identifiers
Product ID 62135-572_2659c503-319a-b899-e063-6294a90aa6a6SPL ID 2659c503-319a-b899-e063-6294a90aa6a6SPL set ID 8ea693ec-e2f2-4661-b144-17651018e9fbRxCUI 313222UNII 012C11ZU6GUPC 0362135572907, 0362135572303
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462135057230 followed by a unit qualifier and the quantity

Package 62135-0572-30. 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)

Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-572

What is NDC 62135-572?
62135-572 is the product NDC for Terbinafine, Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Terbinafine.
What is the active ingredient?
Terbinafine hydrochloride.
Who is the labeler?
Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Terbinafine?
20 other product NDCs are listed under this name. See all Terbinafine 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 Terbinafine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Terbinafineterbinafine hydrochloride tabletTerbinafine hydrochloride 250 mg/1TabletOralAmerisyn LLC87564-01087564-0010-1087564-0010-30
Terbinafineterbinafine hydrochlorideTerbinafine hydrochloride 250 mg/1TabletOralAmerican Health Packaging60687-90960687-0909-21
TerbinafineTerbinafine hydrochloride 250 mg/1TabletOralREMEDYREPACK INC.70518-442170518-4421-0070518-4421-0170518-4421-02+1 more
TerbinafineTerbinafine hydrochloride 250 mg/1TabletOralREMEDYREPACK INC.70518-432370518-4323-0070518-4323-0170518-4323-02
TerbinafineTerbinafine hydrochloride 250 mg/1TabletOraldirect rx72189-24372189-0243-30
Terbinafineterbinafine hydrochlorideTerbinafine hydrochloride 250 mg/1TabletOralREMEDYREPACK INC.70518-294170518-2941-00
TerbinafineTerbinafine hydrochloride 250 mg/1TabletOralCipla USA Inc.69097-85969097-0859-0269097-0859-0769097-0859-12
TerbinafineTerbinafine hydrochloride 250 1/1TabletOralProficient Rx LP71205-15271205-0152-1571205-0152-3071205-0152-35+3 more
TerbinafineTerbinafine hydrochloride 250 mg/1TabletOralExelan Pharmaceuticals Inc.76282-20976282-0209-0176282-0209-0576282-0209-30
Terbinafineterbinafine hydrochlorideTerbinafine hydrochloride 250 mg/1TabletOralNorthStar Rx LLC16714-79516714-0795-0116714-0795-02

All 21 Terbinafine NDCs

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