Prescription drug · ANDA
Valacyclovir Hydrochloride (Valacyclovir) NDC 0378-4275
Valacyclovir hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-4275-77 | 00378427577 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77)Marketed from May 24, 2010 | |
| 0378-4275-93 | 00378427593 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93)Marketed from May 24, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- 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 0378-4275_7de6158d-06ad-4500-a485-dafc151c16ffSPL ID 7de6158d-06ad-4500-a485-dafc151c16ffSPL set ID 56bf715d-8280-4557-9f98-9693932199e5RxCUI 313564, 313565UNII G447S0T1VCUPC 0303784276938, 0303784275931
- 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
N400378427577followed by a unit qualifier and the quantityPackage 00378-4275-77. 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 …
Excerpt only. Read the full label for complete information.
About NDC 0378-4275
- What is NDC 0378-4275?
- 0378-4275 is the product NDC for Valacyclovir Hydrochloride (valacyclovir), Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-144 | 48433-0144-03 |
| 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 |
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 Hydrochloridevalacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4276 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-144 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-093 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2127 |
| 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 Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1341 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-055 |
| Valacyclovir Hydrochloridevalacyclovir | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-106 |