What is NDC 45802-044?

45802-044 is the product NDC for Acyclovir, Acyclovir 50 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 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 45802-044 | National Drug Code

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	4580200447545802004475	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 LtdNDC labeler code 45802
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)

About NDC 45802-044

What is NDC 45802-044?: 45802-044 is the product NDC for Acyclovir, Acyclovir 50 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?: Acyclovir.
What is the active ingredient?: Acyclovir.
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 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 800 mg/1	TabletOral	Aurobindo Pharma Limited	59651-966	59651-0966-0159651-0966-0559651-0966-10
Acyclovir	Acyclovir 400 mg/1	TabletOral	Aurobindo Pharma Limited	59651-965	59651-0965-0159651-0965-0559651-0965-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4450	70518-4450-0070518-4450-01

All 194 Acyclovir NDCs

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