NDC codes

FDA NDC Directory
Product NDC (as listed)13668-515Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0515Add 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 NDC11-digit (billing)PackageCopy
13668-515-011366805150115 g in 1 TUBE (13668-515-01)Marketed from Jan 11, 2019
13668-515-021366805150230 g in 1 TUBE (13668-515-02)Marketed from Jan 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
Ointment
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209971
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 13668-515_82d1c086-8b8a-419e-b5e7-2aa0a1cbf1b9SPL ID 82d1c086-8b8a-419e-b5e7-2aa0a1cbf1b9SPL set ID 1c510390-fb00-4271-967d-0883a9d5e1fdRxCUI 197312UNII X4HES1O11FUPC 0313668515015, 0313668515022
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

N413668051501 followed by a unit qualifier and the quantity

Package 13668-0515-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE: Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209971

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

FDA NDC Directory listings under ANDA 209971
ProductStrengthForm · routeLabelerProduct NDC
acyclovirAcyclovir 50 mg/gOintmentTopicalc68788-4142

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