What is NDC 71205-152?

71205-152 is the product NDC for Terbinafine, Terbinafine hydrochloride 250 1/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Terbinafine NDC 71205-152 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-152Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0152Add 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
71205-152-15	7120501521571205015215	15 TABLET in 1 BOTTLE (71205-152-15)Marketed from Nov 1, 2018
71205-152-30	7120501523071205015230	30 TABLET in 1 BOTTLE (71205-152-30)Marketed from Nov 1, 2018
71205-152-35	7120501523571205015235	35 TABLET in 1 BOTTLE (71205-152-35)Marketed from Nov 1, 2018
71205-152-45	7120501524571205015245	45 TABLET in 1 BOTTLE (71205-152-45)Marketed from Nov 1, 2018
71205-152-60	7120501526071205015260	60 TABLET in 1 BOTTLE (71205-152-60)Marketed from Nov 1, 2018
71205-152-90	7120501529071205015290	90 TABLET in 1 BOTTLE (71205-152-90)Marketed from Nov 1, 2018

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 1/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077533
Marketing start: Jun 27, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Allylamine (Chemical structure)
Identifiers: Product ID 71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2SPL ID 86d7ee5e-ebfd-45ea-a520-b6f65814c3e2SPL set ID 3925dc10-ad66-46a8-bfa5-1a4314be3521RxCUI 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

N471205015215 followed by a unit qualifier and the quantity

Package 71205-0152-15. 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 Jan 1, 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). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-152

What is NDC 71205-152?: 71205-152 is the product NDC for Terbinafine, Terbinafine hydrochloride 250 1/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 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?: Proficient Rx LP, NDC labeler code 71205. 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?: 19 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Terbinafineterbinafine hydrochloride tablet	Terbinafine hydrochloride 250 mg/1	TabletOral	Amerisyn LLC	87564-010	87564-0010-1087564-0010-30
Terbinafineterbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	American Health Packaging	60687-909	60687-0909-21
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-4421	70518-4421-0070518-4421-0170518-4421-02+1 more
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	direct rx	72189-243	72189-0243-30
Terbinafineterbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-2941	70518-2941-00
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	Cipla USA Inc.	69097-859	69097-0859-0269097-0859-0769097-0859-12
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	Exelan Pharmaceuticals Inc.	76282-209	76282-0209-0176282-0209-0576282-0209-30
Terbinafineterbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	NorthStar Rx LLC	16714-795	16714-0795-0116714-0795-02
Terbinafineterbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	A-S Medication Solutions	50090-3575	50090-3575-0050090-3575-01
Terbinafineterbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	A-S Medication Solutions	50090-3654	50090-3654-0050090-3654-01

All 20 Terbinafine NDCs

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	Cipla USA Inc.	69097-859
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-4421
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	Exelan Pharmaceuticals Inc.	76282-209