Prescription drug · ANDA
acyclovir NDC 68462-746
Acyclovir 50 mg/g · Ointment · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-746-17 | 68462074617 | 1 TUBE in 1 CARTON (68462-746-17) / 15 g in 1 TUBEMarketed from Jul 31, 2017 | |
| 68462-746-35 | 68462074635 | 1 TUBE in 1 CARTON (68462-746-35) / 30 g in 1 TUBEMarketed from Jul 31, 2017 |
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 205510
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 68462-746_091cd2ff-6773-415a-9529-4f8386512c41SPL ID 091cd2ff-6773-415a-9529-4f8386512c41SPL set ID 149f4418-7668-4d34-a6f9-69bf3a9c5049RxCUI 197312UNII X4HES1O11FUPC 0368462746356
- 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
N468462074617followed by a unit qualifier and the quantityPackage 68462-0746-17. 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.
Other NDCs under ANDA 205510
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 | OintmentTopical | NuCare Pharmaceuticals, Inc. | 68071-3909 |
| acyclovir | Acyclovir 50 mg/g | OintmentTopical | Northstar Rx LLC | 16714-885 |
| acyclovir | Acyclovir 50 mg/g | OintmentTopical | A-S Medication Solutions | 50090-6561 |