Prescription drug · NDA
Xerese (Acyclovir and hydrocortisone) NDC 0187-5104
Acyclovir 50 mg/g; Hydrocortisone 10 mg/g · Cream · Topical · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5104-01 | 0018751040100187510401 | 1 TUBE in 1 CARTON (0187-5104-01) / 5 g in 1 TUBEMarketed from Jul 31, 2009 |
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)
- Xerese
- Generic name (nonproprietary)
- acyclovir and hydrocortisone
- Active ingredients
- Acyclovir — 50 mg/gHydrocortisone — 10 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 022436
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0187-5104_a4efb63c-e7bf-43da-bbfe-463f672cb1bcSPL ID a4efb63c-e7bf-43da-bbfe-463f672cb1bcSPL set ID 3b6ac164-0f1e-4f36-94a1-1fdb07d710f5RxCUI 998422, 998426UNII X4HES1O11F, WI4X0X7BPJ
- Pharmacologic class
- Corticosteroid; 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
N400187510401followed by a unit qualifier and the quantityPackage 00187-5104-01. 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)
XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and childre…
Excerpt only. Read the full label for complete information.
About NDC 0187-5104
- What is NDC 0187-5104?
- 0187-5104 is the product NDC for Xerese, Acyclovir 50 mg/g; Hydrocortisone 10 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?
- Xerese (Acyclovir and Hydrocortisone).
- What is the active ingredient?
- Acyclovir, Hydrocortisone.
- 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 Xerese?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.