Prescription drug · ANDA
Acyclovir NDC 82804-012
Acyclovir 800 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-012-30 | 82804001230 | 30 TABLET in 1 BOTTLE (82804-012-30)Marketed from Sep 21, 2023 | |
| 82804-012-35 | 82804001235 | 35 TABLET in 1 BOTTLE (82804-012-35)Marketed from Nov 16, 2023 | |
| 82804-012-50 | 82804001250 | 50 TABLET in 1 BOTTLE (82804-012-50)Marketed from Jul 9, 2025 | |
| 82804-012-60 | 82804001260 | 60 TABLET in 1 BOTTLE (82804-012-60)Marketed from Sep 21, 2023 | |
| 82804-012-90 | 82804001290 | 90 TABLET in 1 BOTTLE (82804-012-90)Marketed from Sep 21, 2023 |
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
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210401
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 82804-012_14b524cc-8610-480d-8ce1-ab11f2a9f4d0SPL ID 14b524cc-8610-480d-8ce1-ab11f2a9f4d0SPL set ID d0908b3c-f5dd-4113-9080-bb01abe13c9cRxCUI 197313UNII X4HES1O11FUPC 0382804012305
- 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
N482804001230followed by a unit qualifier and the quantityPackage 82804-0012-30. 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.
About NDC 82804-012
- What is NDC 82804-012?
- 82804-012 is the product NDC for Acyclovir, Acyclovir 800 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acyclovir.
- What is the active ingredient?
- Acyclovir.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acyclovir?
- 193 other product NDCs are listed under this name. See all Acyclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acyclovir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acyclovir | Acyclovir 50 mg/g | OintmentTopical | c | 68788-4142 | 68788-4142-01 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0199 | 55154-0199-00 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-107 | 82868-0107-3082868-0107-35 |
| Acyclovir | Acyclovir 50 mg/g | OintmentTopical | Aryeh Pharma Corp | 85957-036 | 85957-0036-0185957-0036-0285957-0036-03 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-962 | 23155-0962-0123155-0962-05 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-146 | 71921-0146-01 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7519 | 00904-7519-61 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-966 | 59651-0966-0159651-0966-0559651-0966-10 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-965 | 59651-0965-0159651-0965-0559651-0965-10 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4450 | 70518-4450-0070518-4450-01 |
Other NDCs under ANDA 210401
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 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-6578 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-7275 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-7276 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-7277 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Chartwell RX, LLC | 62135-019 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Redpharm Drug | 67296-2162 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Redpharm Drug | 67296-2254 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Preferred Pharmaceuticals Inc | 68788-8724 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | YILING PHARMACEUTICAL, INC. | 69117-0018 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | YILING PHARMACEUTICAL, INC. | 69117-0019 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-137 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-138 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Proficient Rx LP | 71205-472 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1222 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3103 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-587 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Proficient Rx LP | 82804-005 |