Prescription drug · ANDA
Valacyclovir NDC 72789-452
Valacyclovir hydrochloride 1 g/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-452-21 | 7278904522172789045221 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-452-21)Marketed from Nov 18, 2024 |
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)
- Valacyclovir
- Generic name (nonproprietary)
- valacyclovir
- Active ingredients
- Valacyclovir hydrochloride — 1 g/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- 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 72789-452_4d7b15fb-01ce-665a-e063-6294a90abf2aSPL ID 4d7b15fb-01ce-665a-e063-6294a90abf2aSPL set ID e6f54a83-eb07-49d6-b93a-6fe94db323b8RxCUI 313564UNII G447S0T1VCUPC 0372789452210
- 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
N472789045221followed by a unit qualifier and the quantityPackage 72789-0452-21. 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.
About NDC 72789-452
- What is NDC 72789-452?
- 72789-452 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valacyclovir.
- What is the active ingredient?
- Valacyclovir hydrochloride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valacyclovir?
- 53 other product NDCs are listed under this name. See all Valacyclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valacyclovir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-856 | 60760-0856-42 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4661 | 70518-4661-00 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1347 | 67046-1347-03 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1071 | 67046-1071-03 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4105 | 68788-4105-0368788-4105-09 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4417 | 70518-4417-00 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-630 | 72189-0630-2072189-0630-30 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Direct _Rx | 72189-594 | 72189-0594-0472189-0594-1672189-0594-21+1 more |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8705 | 68788-8705-0068788-8705-0168788-8705-02+4 more |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4100 | 70518-4100-0070518-4100-0170518-4100-02+5 more |
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 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 | PD-Rx Pharmaceuticals, Inc. | 43063-771 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2510 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2575 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7702 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | St Mary's Medical Park Pharmacy | 60760-469 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-950 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1071 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1347 |
| 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 1 g/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4805 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7587 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2402 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4417 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0630 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-040 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-041 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-212 |