What is NDC 0378-0896?

0378-0896 is the product NDC for Penciclovir, Penciclovir 10 mg/g cream, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-0896 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0896Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0896Add 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
0378-0896-55	0037808965500378089655	1 TUBE in 1 CARTON (0378-0896-55) / 5 g in 1 TUBEMarketed from Nov 16, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020629
Marketing start: Nov 16, 2022
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 0378-0896_6c831562-21df-42b9-92af-b5da4fcf484fSPL ID 6c831562-21df-42b9-92af-b5da4fcf484fSPL set ID 9cb88c28-d9c9-45e3-b4fe-083327f122deRxCUI 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

N400378089655 followed by a unit qualifier and the quantity

Package 00378-0896-55. 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 Sep 4, 2019.

Indications (excerpt from the label)

Penciclovir cream 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 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 0378-0896

What is NDC 0378-0896?: 0378-0896 is the product NDC for Penciclovir, Penciclovir 10 mg/g cream, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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	Padagis Israel Pharmaceuticals Ltd	45802-440	45802-0440-75
Penciclovir	Penciclovir 10 mg/g	CreamTopical	Teva Pharmaceuticals USA, Inc.	0093-3186	00093-3186-20

Other NDCs under NDA 020629

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

FDA NDC Directory listings under NDA 020629
Product	Strength	Form · route	Labeler	Product NDC
Denavirpenciclovir	Penciclovir 10 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-9720