Prescription drug · NDA
Viread (Tenofovir disoproxil fumarate) NDC 61958-0404
Tenofovir disoproxil fumarate 150 mg/1 · Tablet, Coated · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-0404-1 | 6195804040161958040401 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1)Marketed 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 — 150 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021356
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 61958-0404_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
N461958040401followed by a unit qualifier and the quantityPackage 61958-0404-01. 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.
About NDC 61958-0404
- What is NDC 61958-0404?
- 61958-0404 is the product NDC for Viread (tenofovir disoproxil fumarate), Tenofovir disoproxil fumarate 150 mg/1 tablet, coated, 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?
- Viread (Tenofovir disoproxil fumarate).
- What is the active ingredient?
- Tenofovir disoproxil 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 Viread?
- 4 other product NDCs are listed under this name. See all Viread NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Viread products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 40 mg/g | PowderOral | Gilead Sciences, Inc. | 61958-0403 | 61958-0403-01 |
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 200 mg/1 | Tablet, CoatedOral | Gilead Sciences, Inc. | 61958-0405 | 61958-0405-01 |
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 250 mg/1 | Tablet, CoatedOral | Gilead Sciences, Inc. | 61958-0406 | 61958-0406-01 |
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Gilead Sciences, Inc. | 61958-0401 | 61958-0401-01 |
Other NDCs under NDA 021356
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 |
|---|---|---|---|---|
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Gilead Sciences, Inc. | 61958-0401 |
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 200 mg/1 | Tablet, CoatedOral | Gilead Sciences, Inc. | 61958-0405 |
| Vireadtenofovir disoproxil fumarate | Tenofovir disoproxil fumarate 250 mg/1 | Tablet, CoatedOral | Gilead Sciences, Inc. | 61958-0406 |