Prescription drug · ANDA
acyclovir NDC 72578-002
Acyclovir 200 mg/1 · Capsule · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-002-01 | 72578000201 | 100 CAPSULE in 1 BOTTLE (72578-002-01)Marketed from Aug 23, 2019 | |
| 72578-002-05 | 72578000205 | 500 CAPSULE in 1 BOTTLE (72578-002-05)Marketed from Aug 23, 2019 | |
| 72578-002-06 | 72578000206 | 30 CAPSULE in 1 BOTTLE (72578-002-06)Marketed from Aug 23, 2019 | |
| 72578-002-10 | 72578000210 | 1000 CAPSULE in 1 BOTTLE (72578-002-10)Marketed from Aug 23, 2019 | |
| 72578-002-16 | 72578000216 | 90 CAPSULE in 1 BOTTLE (72578-002-16)Marketed from Aug 23, 2019 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204313
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 72578-002_b797bf2f-d83c-413a-90bf-63c3a0eabf89SPL ID b797bf2f-d83c-413a-90bf-63c3a0eabf89SPL set ID e580b7e9-9060-43f5-9b58-33998078d7e4RxCUI 197310UNII 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
N472578000201followed by a unit qualifier and the quantityPackage 72578-0002-01. 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 capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).
Excerpt only. Read the full label for complete information.
About NDC 72578-002
- What is NDC 72578-002?
- 72578-002 is the product NDC for acyclovir, Acyclovir 200 mg/1 capsule, listed with the FDA by Viona Pharmaceuticals Inc. 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?
- Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-965 | 59651-0965-0159651-0965-0559651-0965-10 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-966 | 59651-0966-0159651-0966-0559651-0966-10 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4450 | 70518-4450-0070518-4450-01 |
Other NDCs under ANDA 204313
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 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7216 |
| acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-965 |
| acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-829 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2526 |
| acyclovir | Acyclovir 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3436 |
| acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2261 |
| acyclovir | Acyclovir 200 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-536 |
| acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Proficient Rx LP | 82804-245 |