What is NDC 43353-893?

43353-893 is the product NDC for Terbinafine Hydrochloride, Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 Hydrochloride?

30 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Terbinafine Hydrochloride NDC 43353-893

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-893Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0893Add 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	Copy
43353-893-16	4335308931643353089316	6000 TABLET in 1 BOTTLE (43353-893-16)Marketed from Feb 26, 2014

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077714
Marketing start: Aug 22, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Allylamine (Chemical structure)
Identifiers: Product ID 43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978SPL ID 280bbc43-14a1-47e0-a702-8cd8117c2978SPL set ID 808dab18-43f1-4895-a023-edbde722863eRxCUI 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

N443353089316 followed by a unit qualifier and the quantity

Package 43353-0893-16. 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 15, 2017.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE 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 43353-893

What is NDC 43353-893?: 43353-893 is the product NDC for Terbinafine Hydrochloride, Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Terbinafine Hydrochloride.
What is the active ingredient?: Terbinafine hydrochloride.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 Hydrochloride?: 30 other product NDCs are listed under this name. See all Terbinafine Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Terbinafine Hydrochlorideterbinafine tablets 250 mg	Terbinafine hydrochloride 250 mg/1	TabletOral	Amici Pharma, Inc.	69292-225	69292-0225-0169292-0225-30
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Scholl's Wellness Company LLC	73469-7215	73469-7215-02
terbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-3907	70518-3907-0170518-3907-03
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	WALGREEN COMPANY	0363-4502	00363-4502-02
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	STRATEGIC SOURCING SERVICES LLC	70677-1003	70677-1003-01
terbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	A-S Medication Solutions	50090-7300	50090-7300-0050090-7300-01
terbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Bionpharma Inc.	69452-351	69452-0351-1369452-0351-20
terbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Bryant Ranch Prepack	71335-9677	71335-9677-0171335-9677-0271335-9677-03+6 more
terbinafine hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Proficient Rx LP	82804-220	82804-0220-3082804-0220-42
Terbinafine Hydrochlorideterbinafine tablets 250 mg	Terbinafine hydrochloride 250 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2381	68071-2381-03

All 31 Terbinafine Hydrochloride NDCs

Other NDCs under ANDA 077714

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

FDA NDC Directory listings under ANDA 077714
Product	Strength	Form · route	Labeler	Product NDC
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-906
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	A-S Medication Solutions	50090-1048
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Northwind Health Company, LLC	51655-364
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-526
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-222
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4500
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Proficient Rx LP	71205-127
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Bryant Ranch Prepack	71335-0918
Terbinafine Hydrochloride	Terbinafine hydrochloride 250 mg/1	TabletOral	Bryant Ranch Prepack	72162-1595