Acyclovir NDC 45802-044

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0044Add 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
45802-044-75	45802004475	1 TUBE in 1 CARTON (45802-044-75) / 5 g in 1 TUBEMarketed from Feb 11, 2019

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: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208702
Marketing start: Feb 11, 2019
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 45802-044_02b3e4ad-6b52-4766-99fb-3edd6119c9b9SPL ID 02b3e4ad-6b52-4766-99fb-3edd6119c9b9SPL set ID 63fadf54-e8a3-4512-8a05-d64b998f5a08RxCUI 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

N445802004475 followed by a unit qualifier and the quantity

Package 45802-0044-75. 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 Mar 31, 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. 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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208702

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

FDA NDC Directory listings under ANDA 208702
Product	Strength	Form · route	Labeler	Product NDC
Acyclovir	Acyclovir 50 mg/g	CreamTopical	Bryant Ranch Prepack	72162-2327