Prescription drug · ANDA
Acyclovir NDC 61442-113
Acyclovir 800 mg/1 · Tablet · Oral · Carlsbad Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61442-113-01 | 61442011301 | 24 BOTTLE, PLASTIC in 1 BOX (61442-113-01) / 100 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 24, 2020 | |
| 61442-113-05 | 61442011305 | 12 BOTTLE, PLASTIC in 1 BOX (61442-113-05) / 500 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 24, 2020 |
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 — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Carlsbad Technology, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075382
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 61442-113_209d3251-8d40-86dc-e063-6394a90a3492SPL ID 209d3251-8d40-86dc-e063-6394a90a3492SPL set ID a68e610a-841c-4b69-9233-673d060561e8RxCUI 197311, 197313UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461442011301followed by a unit qualifier and the quantityPackage 61442-0113-01. 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)
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 075382
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 400 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1735 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9721 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-145 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-146 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-112 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Proficient Rx LP | 71205-053 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Proficient Rx LP | 71205-056 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1053 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4332 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | AvPAK | 50268-061 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | AvPAK | 50268-062 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1678 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2229 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2408 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2447 |