Terbinafine Hydrochloride NDC 55111-250

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-250Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0250Add 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
55111-250-01	55111025001	100 TABLET in 1 BOTTLE (55111-250-01)Marketed from Jul 2, 2007
55111-250-05	55111025005	500 TABLET in 1 BOTTLE (55111-250-05)Marketed from Jul 2, 2007
55111-250-30	55111025030	30 TABLET in 1 BOTTLE (55111-250-30)Marketed from Jul 2, 2007
55111-250-79	55111025079	10 BLISTER PACK in 1 CARTON (55111-250-79) / 10 TABLET in 1 BLISTER PACK (55111-250-78)Marketed from Jul 2, 2007
55111-250-90	55111025090	90 TABLET in 1 BOTTLE (55111-250-90)Marketed from Jul 2, 2007

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 Hydrochloride
Generic name (nonproprietary): terbinafine hydrochloride
Active ingredients: Terbinafine hydrochloride — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr.Reddys Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076390
Marketing start: Jul 2, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Allylamine (Chemical structure)
Identifiers: Product ID 55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057SPL ID 9c427fa5-f0ef-593a-376a-0de7943c4057SPL set ID e0b309a5-bebe-c6da-2847-bda21aa488b1RxCUI 313222UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455111025001 followed by a unit qualifier and the quantity

Package 55111-0250-01. 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 Dec 19, 2024.

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 (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 076390

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

FDA NDC Directory listings under ANDA 076390
Product	Strength	Form · route	Labeler	Product NDC
Terbinafineterbinafine hydrochloride tablet	Terbinafine hydrochloride 250 mg/1	TabletOral	Amerisyn LLC	87564-010
Terbinafine Hydrochlorideterbinafine tablets 250 mg	Terbinafine hydrochloride 250 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-995
Terbinafine Hydrochlorideterbinafine tablets 250 mg	Terbinafine hydrochloride 250 mg/1	TabletOral	Amici Pharma, Inc.	69292-225