What is NDC 72578-101?

72578-101 is the product NDC for Acyclovir, Acyclovir 50 mg/g cream, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acyclovir?

193 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acyclovir NDC 72578-101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0101Add 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
72578-101-04	72578010104	1 TUBE in 1 CARTON (72578-101-04) / 2 g in 1 TUBEMarketed from Mar 3, 2023
72578-101-05	72578010105	1 TUBE in 1 CARTON (72578-101-05) / 5 g in 1 TUBEMarketed from Mar 3, 2023

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): Acyclovir
Generic name (nonproprietary): acyclovir
Active ingredients: Acyclovir — 50 mg/g
Dosage form: Cream
Route: Topical
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206770
Marketing start: Mar 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 72578-101_611d8237-2516-413c-81c3-99252bb5f597SPL ID 611d8237-2516-413c-81c3-99252bb5f597SPL set ID a2966b6d-c6c0-4afd-8eda-045df497cb9dRxCUI 141859UNII X4HES1O11F
Pharmacologic class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; 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

N472578010104 followed by a unit qualifier and the quantity

Package 72578-0101-04. 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 6, 2024.

Indications (excerpt from the label)

Acyclovir cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. ( 1 ) Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-101

What is NDC 72578-101?: 72578-101 is the product NDC for Acyclovir, Acyclovir 50 mg/g cream, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acyclovir.
What is the active ingredient?: Acyclovir.
Who is the labeler?: Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acyclovir?: 193 other product NDCs are listed under this name. See all Acyclovir 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 Acyclovir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
acyclovir	Acyclovir 50 mg/g	OintmentTopical	c	68788-4142	68788-4142-01
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0199	55154-0199-00
acyclovir	Acyclovir 800 mg/1	TabletOral	Northwind Health Company, LLC	82868-107	82868-0107-3082868-0107-35
Acyclovir	Acyclovir 50 mg/g	OintmentTopical	Aryeh Pharma Corp	85957-036	85957-0036-0185957-0036-0285957-0036-03
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Avet Pharmaceuticals Inc.	23155-962	23155-0962-0123155-0962-05
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Florida Pharmaceutical Products, LLC	71921-146	71921-0146-01
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7519	00904-7519-61
Acyclovir	Acyclovir 400 mg/1	TabletOral	Aurobindo Pharma Limited	59651-965	59651-0965-0159651-0965-0559651-0965-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	Aurobindo Pharma Limited	59651-966	59651-0966-0159651-0966-0559651-0966-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4450	70518-4450-0070518-4450-01

All 194 Acyclovir NDCs

Other NDCs under ANDA 206770

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

FDA NDC Directory listings under ANDA 206770
Product	Strength	Form · route	Labeler	Product NDC
Acyclovir	Acyclovir 50 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1808