Prescription drug · ANDA
Valacyclovir Hydrochloride (Valacyclovir) NDC 48433-144
Valacyclovir hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-144-03 | 48433014403 | 30 BLISTER PACK in 1 CARTON (48433-144-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-144-01)Marketed from Apr 3, 2026 |
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 Hydrochloride
- Generic name (nonproprietary)
- valacyclovir
- Active ingredients
- Valacyclovir hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Safecor Health LLCNDC labeler code 48433
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078518
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 48433-144_52e67437-4852-95b6-e063-6394a90aaf15SPL ID 52e67437-4852-95b6-e063-6394a90aaf15SPL set ID 021ab9d0-7b75-40cf-afde-446942d64388RxCUI 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
N448433014403followed by a unit qualifier and the quantityPackage 48433-0144-03. 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 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.
About NDC 48433-144
- What is NDC 48433-144?
- 48433-144 is the product NDC for Valacyclovir Hydrochloride (valacyclovir), Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Safecor Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valacyclovir Hydrochloride (Valacyclovir).
- What is the active ingredient?
- Valacyclovir hydrochloride.
- Who is the labeler?
- Safecor Health LLC, NDC labeler code 48433. 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 Hydrochloride?
- 56 other product NDCs are listed under this name. See all Valacyclovir Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valacyclovir Hydrochloride 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 Hydrochloridevalacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-106 | 82868-0106-21 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8904 | 68788-8904-0368788-8904-09 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8820 | 68788-8820-0068788-8820-0168788-8820-02+4 more |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-757 | 60760-0757-42 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-055 | 82868-0055-21 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8482 | 68788-8482-0368788-8482-09 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-703 | 51655-0703-0451655-0703-2151655-0703-53 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-633 | 51655-0633-2151655-0633-84 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3359 | 70518-3359-0170518-3359-0270518-3359-03 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-691 | 49483-0691-0149483-0691-0349483-0691-04+1 more |
Other NDCs under ANDA 078518
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 Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-093 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1341 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8482 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0541 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2127 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-055 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4275 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4276 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-106 |