Prescription drug · ANDA
Famciclovir NDC 64980-349
Famciclovir 125 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-349-03 | 64980034903 | 30 TABLET, FILM COATED in 1 BOTTLE (64980-349-03)Marketed from Mar 21, 2011 |
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)
- Famciclovir
- Generic name (nonproprietary)
- famciclovir
- Active ingredients
- Famciclovir — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091114
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 64980-349_edd6ee53-72b7-48e5-aef4-30c077db7545SPL ID edd6ee53-72b7-48e5-aef4-30c077db7545SPL set ID d5c46506-a350-44a1-9440-d939da895f16RxCUI 198382, 199192, 199193UNII QIC03ANI02
- Pharmacologic class
- 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
N464980034903followed by a unit qualifier and the quantityPackage 64980-0349-03. 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)
Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients (1.1) Herpes labialis (cold sores) Treatment of recurrent episodes Genital herpes Treatment of recurrent episodes Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients (1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes o…
Excerpt only. Read the full label for complete information.
About NDC 64980-349
- What is NDC 64980-349?
- 64980-349 is the product NDC for Famciclovir, Famciclovir 125 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Famciclovir.
- What is the active ingredient?
- Famciclovir.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Famciclovir?
- 25 other product NDCs are listed under this name. See all Famciclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Famciclovir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Famciclovir | Famciclovir 125 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-091 | 73190-0091-30 |
| Famciclovir | Famciclovir 250 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-092 | 73190-0092-30 |
| Famciclovir | Famciclovir 500 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-093 | 73190-0093-30 |
| Famciclovir | Famciclovir 125 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-414 | 42291-0414-30 |
| Famciclovir | Famciclovir 250 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-415 | 42291-0415-30 |
| Famciclovir | Famciclovir 500 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-416 | 42291-0416-30 |
| Famciclovir | Famciclovir 125 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-706 | 31722-0706-0131722-0706-0531722-0706-10+2 more |
| Famciclovir | Famciclovir 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7890 | 63629-7890-01 |
| Famciclovir | Famciclovir 250 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-707 | 31722-0707-0131722-0707-0531722-0707-10+2 more |
| Famciclovir | Famciclovir 500 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-708 | 31722-0708-0131722-0708-0531722-0708-10+2 more |
Other NDCs under ANDA 091114
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 |
|---|---|---|---|---|
| Famciclovir | Famciclovir 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-467 |
| Famciclovir | Famciclovir 125 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-465 |
| Famciclovir | Famciclovir 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-466 |
| Famciclovir | Famciclovir 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-351 |
| Famciclovir | Famciclovir 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-350 |