Prescription drug · NDA
Viread (tenofovir disoproxil fumarate) NDC 61958-0403
Tenofovir disoproxil fumarate 40 mg/g · Powder · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-0403-1 | 61958040301 | 1 BOTTLE, PLASTIC in 1 CARTON (61958-0403-1) / 60 g in 1 BOTTLE, PLASTICMarketed from Jan 18, 2012 |
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)
- Viread
- Generic name (nonproprietary)
- tenofovir disoproxil fumarate
- Active ingredients
- Tenofovir disoproxil fumarate — 40 mg/g
- Dosage form
- Powder
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022577
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 61958-0403_1b2267fa-9978-4429-ac13-09a5d43b3093SPL ID 1b2267fa-9978-4429-ac13-09a5d43b3093SPL set ID 33fd6418-fbdc-42ca-a50d-ce2a476a5418RxCUI 349251, 352050, 1243227, 1243229, 1243324, 1243326, 1243328, 1243330, 1243343, 1243346UNII OTT9J7900I
- 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
N461958040301followed by a unit qualifier and the quantityPackage 61958-0403-01. 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)
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. ( 1.2 ) 1.1 HIV-1 Infection VIREAD is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.2 Chronic Hepatitis B …
Excerpt only. Read the full label for complete information.