Prescription drug · ANDA
Valacyclovir NDC 70518-4100
Valacyclovir hydrochloride 1000 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4100-0 | 70518410000 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4100-0)Marketed from Jun 12, 2024 | |
| 70518-4100-1 | 70518410001 | 21 TABLET in 1 BOTTLE, PLASTIC (70518-4100-1)Marketed from Jun 12, 2024 | |
| 70518-4100-2 | 70518410002 | 14 TABLET in 1 BOTTLE, PLASTIC (70518-4100-2)Marketed from Jun 12, 2024 | |
| 70518-4100-3 | 70518410003 | 7 TABLET in 1 BOTTLE, PLASTIC (70518-4100-3)Marketed from Jul 9, 2024 | |
| 70518-4100-4 | 70518410004 | 4 TABLET in 1 BOTTLE, PLASTIC (70518-4100-4)Marketed from Aug 4, 2024 | |
| 70518-4100-5 | 70518410005 | 10 TABLET in 1 BOTTLE, PLASTIC (70518-4100-5)Marketed from Apr 2, 2025 | |
| 70518-4100-6 | 70518410006 | 20 TABLET in 1 BOTTLE, PLASTIC (70518-4100-6)Marketed from Aug 23, 2025 | |
| 70518-4100-7 | 70518410007 | 5 TABLET in 1 BOTTLE, PLASTIC (70518-4100-7)Marketed from Jul 23, 2026 |
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)
- Valacyclovir
- Generic name (nonproprietary)
- valacyclovir
- Active ingredients
- Valacyclovir hydrochloride — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209553
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 70518-4100_5749248a-d262-6d55-e063-6394a90ade97SPL ID 5749248a-d262-6d55-e063-6394a90ade97SPL set ID 5e39bf80-ada6-4194-bf3d-2c044c3389daRxCUI 313564UNII G447S0T1VC
- 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
N470518410000followed by a unit qualifier and the quantityPackage 70518-4100-00. 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)
Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission Herpes Zoster Pediatric Patients ( 1.2 ) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3 ) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209553
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 |
|---|---|---|---|---|
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3624 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Redpharm Drug | 67296-2146 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-586 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Chartwell RX, LLC | 62135-613 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-856 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | TabletOral | Chartwell RX, LLC | 62135-614 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7484 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Proficient Rx LP | 82804-009 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Proficient Rx LP | 82804-006 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Sportpharm LLC | 85766-271 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Sportpharm LLC | 85766-270 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4105 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6581 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2534 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8705 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7270 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Direct _Rx | 72189-594 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-262 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-263 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2566 |
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