What is NDC 68788-9814?

68788-9814 is the product NDC for Terbinafine Hydrochloride, Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Preferred Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals, Inc, NDC labeler code 68788. 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 68788-9814

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-9814Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-9814Add 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
68788-9814-1	6878898140168788981401	15 g in 1 TUBE (68788-9814-1)Marketed from Apr 5, 2012
68788-9814-3	6878898140368788981403	30 g in 1 TUBE (68788-9814-3)Marketed from Apr 5, 2012

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1 g/100g
Dosage form: Cream
Route: Topical
Labeler: Preferred Pharmaceuticals, IncNDC labeler code 68788
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077511
Marketing start: Apr 5, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Allylamine (Chemical structure)
Identifiers: Product ID 68788-9814_b4fb8580-3d3a-4d64-ac02-15617f4df9efSPL ID b4fb8580-3d3a-4d64-ac02-15617f4df9ef
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468788981401 followed by a unit qualifier and the quantity

Package 68788-9814-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-9814

What is NDC 68788-9814?: 68788-9814 is the product NDC for Terbinafine Hydrochloride, Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Preferred Pharmaceuticals, Inc. It has 2 package NDCs, 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?: Preferred Pharmaceuticals, Inc, NDC labeler code 68788. 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 077511

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

FDA NDC Directory listings under ANDA 077511
Product	Strength	Form · route	Labeler	Product NDC
Antifungalterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Meijer Distribution Inc	41250-080
Athletes Footterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Rite Aid Corporation	11822-0080
Athletes Footterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	H E B	37808-080
Athletes Footterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Publix Super Markets Inc.	56062-080
Curist Antifungal Reliefterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Little Pharma, Inc.	72559-035
Cvsterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	CVS Pharmacy	59779-523
CVS Pharmacy Athletes Footterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	CVS Pharmacy	59779-080
equate Athletes Footterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Wal-Mart Stores Inc	49035-080
Good Neighbor Pharmacyterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	AmerisourceBergen	24385-524
Good Neighbor Pharmacyterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-4044
Kroger Antifungalterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Kroger Company	30142-080
Silka Antifungalterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Genomma Lab USA, Inc.	50066-080
Silka Jock Itchterbinafine hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Genomma Lab USA, Inc.	50066-208
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	WALGREEN COMPANY	0363-4502
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	A-S Medication Solutions	50090-1278
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	A-S Medication Solutions	50090-5810
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-2080
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-2140
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Proficient Rx LP	63187-111
Terbinafine Hydrochloride	Terbinafine hydrochloride 1 g/100g	CreamTopical	Cardinal Health, 110 dba LEADER	70000-0338

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