Prescription drug · ANDA
Valacyclovir NDC 71335-0630
Valacyclovir hydrochloride 1 g/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0630-0 | 71335063000 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0630-0)Marketed from Oct 5, 2021 | |
| 71335-0630-1 | 71335063001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0630-1)Marketed from May 29, 2018 | |
| 71335-0630-2 | 71335063002 | 21 TABLET, FILM COATED in 1 BOTTLE (71335-0630-2)Marketed from Mar 21, 2018 | |
| 71335-0630-3 | 71335063003 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0630-3)Marketed from Jul 24, 2018 | |
| 71335-0630-4 | 71335063004 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-0630-4)Marketed from Jul 13, 2018 | |
| 71335-0630-5 | 71335063005 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-0630-5)Marketed from May 28, 2019 | |
| 71335-0630-6 | 71335063006 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-0630-6)Marketed from Mar 20, 2018 | |
| 71335-0630-7 | 71335063007 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0630-7)Marketed from Mar 4, 2019 | |
| 71335-0630-8 | 71335063008 | 8 TABLET, FILM COATED in 1 BOTTLE (71335-0630-8)Marketed from May 29, 2018 | |
| 71335-0630-9 | 71335063009 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0630-9)Marketed from Feb 18, 2020 |
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 — 1 g/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203047
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 71335-0630_375e88d9-f545-4d58-bad6-f0281802d93cSPL ID 375e88d9-f545-4d58-bad6-f0281802d93cSPL set ID e5f5223f-569c-40c6-a3c7-381bc61cf8c6RxCUI 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
N471335063000followed by a unit qualifier and the quantityPackage 71335-0630-00. 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 tablet is 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 fo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203047
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 1 g/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-041 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7702 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-212 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2402 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7587 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4805 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3747 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3749 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3749 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2510 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1071 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2575 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-452 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-704 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-705 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | St Mary's Medical Park Pharmacy | 60760-469 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4417 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1347 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-771 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-950 |
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