What is NDC 45802-440?

45802-440 is the product NDC for Penciclovir, Penciclovir 10 mg/g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Penciclovir?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Penciclovir NDC 45802-440 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0440Add 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
45802-440-75	4580204407545802044075	1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBEMarketed from Nov 7, 2024

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): Penciclovir
Generic name (nonproprietary): penciclovir
Active ingredients: Penciclovir — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212368
Marketing start: Nov 7, 2024
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2cSPL ID aa3c82bd-5e27-4b4d-af88-6b80e5779f2cSPL set ID 72da67d0-1349-4408-be13-9935bd9c0179RxCUI 312255UNII 359HUE8FJC
Pharmacologic class: Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor

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

N445802044075 followed by a unit qualifier and the quantity

Package 45802-0440-75. 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 31, 2025.

Indications (excerpt from the label)

Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-440

What is NDC 45802-440?: 45802-440 is the product NDC for Penciclovir, Penciclovir 10 mg/g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Penciclovir.
What is the active ingredient?: Penciclovir.
Who is the labeler?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Penciclovir?: 3 other product NDCs are listed under this name. See all Penciclovir 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 Penciclovir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Penciclovir	Penciclovir 10 mg/g	CreamTopical	Amneal Pharmaceuticals NY LLC	69238-1791	69238-1791-07
Penciclovir	Penciclovir 10 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-0896	00378-0896-55
Penciclovir	Penciclovir 10 mg/g	CreamTopical	Teva Pharmaceuticals USA, Inc.	0093-3186	00093-3186-20