Prescription drug · NDA AUTHORIZED GENERIC
Acyclovir NDC 0591-1159
Acyclovir 50 mg/g · Ointment · Topical · ACTAVIS PHARMA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-1159-30 | 00591115930 | 1 TUBE in 1 CARTON (0591-1159-30) / 30 g in 1 TUBEMarketed from Apr 11, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- ACTAVIS PHARMA, INC.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018604
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0591-1159_9a0c599a-742a-48f5-ae69-cd9e8cbaa604SPL ID 9a0c599a-742a-48f5-ae69-cd9e8cbaa604SPL set ID b360a808-a24d-4f3c-89a7-9941422d17d6RxCUI 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
N400591115930followed by a unit qualifier and the quantityPackage 00591-1159-30. 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-lifethreatening mucocutaneous HSV infections in immunocompromised patients.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018604
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zoviraxacyclovir | Acyclovir 50 mg/g | OintmentTopical | Bausch Health US, LLC | 0187-0993 |