Prescription drug · ANDA
Valacyclovir NDC 68788-4105
Valacyclovir hydrochloride 500 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4105-3 | 6878841050368788410503 | 30 TABLET in 1 BOTTLE (68788-4105-3)Marketed from Apr 21, 2026 | |
| 68788-4105-9 | 6878841050968788410509 | 90 TABLET in 1 BOTTLE (68788-4105-9)Marketed from Apr 21, 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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-4105_890f45c7-191b-4d60-8c52-ed92c2319eb3SPL ID 890f45c7-191b-4d60-8c52-ed92c2319eb3SPL set ID 890f45c7-191b-4d60-8c52-ed92c2319eb3RxCUI 313565UNII 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
N468788410503followed by a unit qualifier and the quantityPackage 68788-4105-03. 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 o Treatment in immunocompetent patients (initial or recurrent episode) o Suppression in immunocompetent or HIV-1-infected patients o 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 indicate…
Excerpt only. Read the full label for complete information.
About NDC 68788-4105
- What is NDC 68788-4105?
- 68788-4105 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 500 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 package NDCs, 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 | 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 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6581 | 50090-6581-0050090-6581-0150090-6581-02+1 more |
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 500 mg/1 | TabletOral | Yiling Pharmaceutical, Inc. | 69117-0010 |
| Valacyclovirvalacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | TabletOral | Yiling Pharmaceutical, Inc. | 69117-0011 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2534 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3624 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Direct _Rx | 72189-594 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Redpharm Drug | 67296-2146 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-349 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-350 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-630 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Sportpharm LLC | 85766-270 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | Sportpharm LLC | 85766-271 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7484 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6581 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-856 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Chartwell RX, LLC | 62135-613 |
| Valacyclovir | Valacyclovir hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2566 |
| Valacyclovir | Valacyclovir hydrochloride 1 g/1 | TabletOral | Chartwell RX, LLC | 62135-614 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7270 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-586 |
| Valacyclovir | Valacyclovir hydrochloride 1000 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-5342 |
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