Prescription drug · NDA
Truvada NDC 61958-0701
emtricitabine and tenofovir disoproxil fumarate · Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Film coated · Oral · Gilead Sciences, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-0701-1 | 61958070101 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1)Marketed from Aug 2, 2004 |
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)
- Truvada
- Generic name (nonproprietary)
- emtricitabine and tenofovir disoproxil fumarate
- Active ingredients
- Emtricitabine — 200 mg/1Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Gilead Sciences, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021752
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
- Identifiers
- Product ID 61958-0701_32422ee8-1cdc-4305-bb3e-0458472513fcSPL ID 32422ee8-1cdc-4305-bb3e-0458472513fcSPL set ID 54e82b13-a037-49ed-b4b3-030b37c0ecddRxCUI 476556, 639888, 1744001, 1744003, 1744005, 1744007, 1744009, 1744011UNII G70B4ETF4S, 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
N461958070101followed by a unit qualifier and the quantityPackage 61958-0701-01. 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)
HIV-1 Treatment ( 1.1 ) TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP. 1.1 Treatment of HIV-1 Infection TRUVADA is indicated in combi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021752
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 |
|---|---|---|---|---|
| Truvadaemtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2112 |
| Truvadaemtricitabine and tenofovir disoproxil fumarate | Emtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1 | Tablet, Film coatedOral | Gilead Sciences, Inc | 61958-0703 |
| Truvadaemtricitabine and tenofovir disoproxil fumarate | Emtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1 | Tablet, Film coatedOral | Gilead Sciences, Inc | 61958-0704 |
| Truvadaemtricitabine and tenofovir disoproxil fumarate | Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 | Tablet, Film coatedOral | Gilead Sciences, Inc | 61958-0705 |