Prescription drug · NDA
Zovirax (Acyclovir) NDC 0187-0994
Acyclovir 50 mg/g · Cream · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0994-45 | 0018709944500187099445 | 1 TUBE in 1 CARTON (0187-0994-45) / 5 g in 1 TUBEMarketed from Dec 30, 2002 |
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)
- Zovirax
- Generic name (nonproprietary)
- acyclovir
- Active ingredients
- Acyclovir — 50 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bausch Health US, LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021478
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0187-0994_beac4f87-cacc-4345-be9e-b105f6db7ee2SPL ID beac4f87-cacc-4345-be9e-b105f6db7ee2SPL set ID 125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2RxCUI 141859, 825321UNII X4HES1O11FUPC 0301870994452
- 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
N400187099445followed by a unit qualifier and the quantityPackage 00187-0994-45. 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)
ZOVIRAX 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. ZOVIRAX 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.
About NDC 0187-0994
- What is NDC 0187-0994?
- 0187-0994 is the product NDC for Zovirax (acyclovir), Acyclovir 50 mg/g cream, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zovirax (Acyclovir).
- What is the active ingredient?
- Acyclovir.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zovirax?
- 1 other product NDC are listed under this name. See all Zovirax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zovirax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zoviraxacyclovir | Acyclovir 50 mg/g | OintmentTopical | Bausch Health US, LLC | 0187-0993 | 00187-0993-95 |
Other NDCs under NDA 021478
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 |
|---|---|---|---|---|
| Acyclovir | Acyclovir 50 mg/g | CreamTopical | Teva Pharmaceuticals USA, Inc. | 0093-3630 |