Prescription drug · ANDA
acyclovir NDC 76420-050
Acyclovir 400 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-050-15 | 76420005015 | 15 TABLET in 1 BOTTLE (76420-050-15)Marketed from Sep 25, 2020 | |
| 76420-050-30 | 76420005030 | 30 TABLET in 1 BOTTLE (76420-050-30)Marketed from Sep 25, 2020 | |
| 76420-050-60 | 76420005060 | 60 TABLET in 1 BOTTLE (76420-050-60)Marketed from Sep 25, 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 — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077309
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 76420-050_b01ced44-7b5d-5716-e053-2995a90a1263SPL ID b01ced44-7b5d-5716-e053-2995a90a1263SPL set ID e186fdc9-b60e-4280-8d60-36cae9f2838fRxCUI 197311UNII 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
N476420005015followed by a unit qualifier and the quantityPackage 76420-0050-15. 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 tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir tablets are indicated for the treatment of chickenpox (varicella).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077309
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 | REMEDYREPACK INC. | 70518-0427 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1381 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5100 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2247 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | Proficient Rx LP | 71205-391 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2287 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9174 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | Apotex Corp. | 60505-5306 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Apotex Corp. | 60505-5307 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1724 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Proficient Rx LP | 63187-192 |