Prescription drug · ANDA
Emtricitabine and tenofovir disoproxil fumarate NDC 70710-1366
Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1366-3 | 70710136603 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1366-3)Marketed from Jul 1, 2021 | |
| 70710-1366-4 | 70710136604 | 10 BLISTER PACK in 1 CARTON (70710-1366-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1366-2)Marketed from Jul 1, 2021 | |
| 70710-1366-9 | 70710136609 | 90 TABLET, FILM COATED in 1 BOTTLE (70710-1366-9)Marketed from Jul 1, 2021 |
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)
- Emtricitabine and tenofovir disoproxil fumarate
- Generic name (nonproprietary)
- emtricitabine and tenofovir disoproxil fumarate
- Active ingredients
- Emtricitabine — 167 mg/1Tenofovir disoproxil fumarate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212689
- 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 70710-1366_919c0aaa-f6d2-426d-a673-ef5c806f9a3aSPL ID 919c0aaa-f6d2-426d-a673-ef5c806f9a3aSPL set ID 7def7a95-e69e-4985-974a-efacadcecc95RxCUI 476556, 1744001, 1744005, 1744009UNII 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
N470710136603followed by a unit qualifier and the quantityPackage 70710-1366-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
HIV-1 Treatment ( 1.1 ) Emtricitabine and tenofovir disoproxil fumarate tablets are 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 ): Emtricitabine and tenofovir disoproxil fumarate tablets are 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 i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212689
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 |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1622 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1620 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1621 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1709 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1364 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1365 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1367 |