Prescription drug · ANDA
Acyclovir NDC 0472-0082
Acyclovir 200 mg/5mL · Suspension · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0472-0082-16 | 00472008216 | 473 mL in 1 BOTTLE (0472-0082-16)Marketed from Sep 3, 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)
- Acyclovir
- Generic name (nonproprietary)
- acyclovir
- Active ingredients
- Acyclovir — 200 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074738
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0472-0082_6f58843b-1a91-42b4-b03c-7cad93c931d6SPL ID 6f58843b-1a91-42b4-b03c-7cad93c931d6SPL set ID a4c1305c-f18c-4fb0-83d8-2822341f2dfaRxCUI 307730UNII X4HES1O11FUPC 0304720082163
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400472008216followed by a unit qualifier and the quantityPackage 00472-0082-16. 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 Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir is indicated for the treatment of chickenpox (varicella).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074738
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.