Terbinafine NDC 76282-209

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-209Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0209Add 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 NDC	11-digit (billing)	Package
76282-209-01	76282020901	100 TABLET in 1 BOTTLE (76282-209-01)Marketed from Apr 25, 2012
76282-209-05	76282020905	500 TABLET in 1 BOTTLE (76282-209-05)Marketed from Apr 25, 2012
76282-209-30	76282020930	30 TABLET in 1 BOTTLE (76282-209-30)Marketed from Apr 25, 2012

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: Exelan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077533
Marketing start: Apr 25, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Allylamine (Chemical structure)
Identifiers: Product ID 76282-209_dc86cdd6-0a8a-4e5c-b3c4-8b05388af862SPL ID dc86cdd6-0a8a-4e5c-b3c4-8b05388af862SPL set ID 6dc279cc-9861-4fa8-8083-ca3b3c57b513RxCUI 313222UNII 012C11ZU6GUPC 0376282209302
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

N476282020901 followed by a unit qualifier and the quantity

Package 76282-0209-01. 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 Oct 29, 2020.

Indications (excerpt from the label)

Terbinafine tablets, USP 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).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077533

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077533
Product	Strength	Form · route	Labeler	Product NDC
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-4323
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	Cipla USA Inc.	69097-859
Terbinafine	Terbinafine hydrochloride 250 1/1	TabletOral	Proficient Rx LP	71205-152
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-4421