Prescription drug · NDA
Vemlidy (Tenofovir alafenamide) NDC 61958-2301
Tenofovir alafenamide fumarate 25 mg/1 · Tablet · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-2301-1 | 6195823010161958230101 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)Marketed from Nov 10, 2016 |
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)
- Vemlidy
- Generic name (nonproprietary)
- tenofovir alafenamide
- Active ingredients
- Tenofovir alafenamide fumarate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208464
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 61958-2301_175f5d1a-aae9-43d5-b004-65eefec167d4SPL ID 175f5d1a-aae9-43d5-b004-65eefec167d4SPL set ID 72e6b33c-0351-4070-9172-eeaa186c01d2RxCUI 1858261, 1858267UNII FWF6Q91TZO
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase 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
N461958230101followed by a unit qualifier and the quantityPackage 61958-2301-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ] . VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 61958-2301
- What is NDC 61958-2301?
- 61958-2301 is the product NDC for Vemlidy (tenofovir alafenamide), Tenofovir alafenamide fumarate 25 mg/1 tablet, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vemlidy (Tenofovir alafenamide).
- What is the active ingredient?
- Tenofovir alafenamide fumarate.
- Who is the labeler?
- Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vemlidy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.