Prescription drug · ANDA
Emtricitabine and Tenofovir Disoproxil Fumarate NDC 42543-719
Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 · Tablet · Oral · Strides Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42543-719-04 | 42543071904 | 30 TABLET in 1 BOTTLE, PLASTIC (42543-719-04)Marketed from Mar 30, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 200 mg/1Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strides Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091055
- 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 42543-719_427e3960-fb3a-429d-8651-b62e7b97479dSPL ID 427e3960-fb3a-429d-8651-b62e7b97479dSPL set ID 7ecc604c-c4b4-4419-a733-ecb11662fc81RxCUI 476556UNII G70B4ETF4S, OTT9J7900IUPC 0342543719040
- 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
N442543071904followed by a unit qualifier and the quantityPackage 42543-0719-04. 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 initi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091055
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 | TabletOral | Golden State Medical Supply, Inc. | 51407-112 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-719 |