Prescription drug · ANDA
Emtricitabine and Tenofovir Disoproxil Fumarate NDC 69238-2092
Emtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2092-3 | 69238209203 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-2092-3)Marketed from Aug 26, 2018 |
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 — 100 mg/1Tenofovir disoproxil fumarate — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209721
- 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 69238-2092_e3f72707-b2b3-49e4-8b28-a9311e1358cfSPL ID e3f72707-b2b3-49e4-8b28-a9311e1358cfSPL set ID b0459301-2bff-4336-9172-b90c7a582433RxCUI 476556, 1744001, 1744005, 1744009UNII OTT9J7900I, G70B4ETF4SUPC 0369238209433, 0369238209532, 0369238209235, 0369238209334
- 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
N469238209203followed by a unit qualifier and the quantityPackage 69238-2092-03. 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 tablet 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 ): 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209721
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 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-2095 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2093 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2094 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2095 |