NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6561Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6561Add 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
50090-6561-0500906561001 TUBE in 1 CARTON (50090-6561-0) / 15 g in 1 TUBEMarketed from Jul 18, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 205510
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 50090-6561_7db2d685-8704-4f12-a2c3-23d22d22acd8SPL ID 7db2d685-8704-4f12-a2c3-23d22d22acd8SPL set ID 942632d8-08cd-4003-aec0-1c6d5c09bc15RxCUI 197312UNII 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

N450090656100 followed by a unit qualifier and the quantity

Package 50090-6561-00. 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 USP 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 205510

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

FDA NDC Directory listings under ANDA 205510
ProductStrengthForm · routeLabelerProduct NDC
acyclovirAcyclovir 50 mg/gOintmentTopicalNuCare Pharmaceuticals, Inc.68071-3909
acyclovirAcyclovir 50 mg/gOintmentTopicalNorthstar Rx LLC16714-885
acyclovirAcyclovir 50 mg/gOintmentTopicalGlenmark Pharmaceuticals Inc., USA68462-746

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