Prescription drug · ANDA
acyclovir NDC 70518-1614
Acyclovir 800 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1614-0 | 70518161400 | 30 TABLET in 1 BLISTER PACK (70518-1614-0)Marketed from Oct 29, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204314
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 70518-1614_4e921ba6-8b1f-c638-e063-6394a90a61b8SPL ID 4e921ba6-8b1f-c638-e063-6394a90a61b8SPL set ID 960e4ede-692e-4db2-a96e-dc6f4a6190eeRxCUI 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
N470518161400followed by a unit qualifier and the quantityPackage 70518-1614-00. 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 204314
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 | A-S Medication Solutions | 50090-3250 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Coupler LLC | 67046-1487 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-802 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-803 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Proficient Rx LP | 63187-366 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-791 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-792 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1363 |
| acyclovir | Acyclovir 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-3254 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-107 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-399 |