What is NDC 70518-4421?

70518-4421 is the product NDC for Terbinafine, Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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 70518-4421 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4421Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4421Add 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
70518-4421-0	7051844210070518442100	90 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0)Marketed from Aug 4, 2025
70518-4421-1	7051844210170518442101	45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1)Marketed from Aug 22, 2025
70518-4421-2	7051844210270518442102	30 TABLET in 1 BLISTER PACK (70518-4421-2)Marketed from Sep 2, 2025
70518-4421-3	7051844210370518442103	30 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3)Marketed from Sep 10, 2025

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
Generic name (nonproprietary): terbinafine
Active ingredients: Terbinafine hydrochloride — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077533
Marketing start: Aug 4, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Allylamine (Chemical structure)
Identifiers: Product ID 70518-4421_5b24a338-a25d-eedb-e063-6394a90a4440SPL ID 5b24a338-a25d-eedb-e063-6394a90a4440
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

N470518442100 followed by a unit qualifier and the quantity

Package 70518-4421-00. 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 70518-4421

What is NDC 70518-4421?: 70518-4421 is the product NDC for Terbinafine, Terbinafine hydrochloride 250 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 4 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?: REMEDYREPACK INC., NDC labeler code 70518. 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	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 1/1	TabletOral	Proficient Rx LP	71205-152	71205-0152-1571205-0152-3071205-0152-35+3 more
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 1/1	TabletOral	Proficient Rx LP	71205-152
Terbinafine	Terbinafine hydrochloride 250 mg/1	TabletOral	Exelan Pharmaceuticals Inc.	76282-209