Prescription drug · ANDA
Emtricitabine and tenofovir disoproxil fumarate NDC 68071-3695
Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3695-3 | 6807136950368071369503 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-3695-3)Marketed from Oct 4, 2024 |
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 — 200 mg/1Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203442
- 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 68071-3695_2a31e80a-2d19-b23c-e063-6394a90a1aecSPL ID 2a31e80a-2d19-b23c-e063-6394a90a1aecSPL set ID 23ae0a72-adcf-fdd0-e063-6394a90abe63RxCUI 476556UNII G70B4ETF4S, OTT9J7900IUPC 0368071369533
- 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
N468071369503followed by a unit qualifier and the quantityPackage 68071-3695-03. 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 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 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 initi…
Excerpt only. Read the full label for complete information.
About NDC 68071-3695
- What is NDC 68071-3695?
- 68071-3695 is the product NDC for Emtricitabine and tenofovir disoproxil fumarate, Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Emtricitabine and tenofovir disoproxil fumarate.
- What is the active ingredient?
- Emtricitabine, Tenofovir disoproxil fumarate.
- Who is the labeler?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Emtricitabine and tenofovir disoproxil fumarate?
- 42 other product NDCs are listed under this name. See all Emtricitabine and tenofovir disoproxil fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Emtricitabine and tenofovir disoproxil fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-980 | 42291-0980-30 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-109 | 82009-0109-30 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 100 mg/1; Tenofovir disoproxil fumarate 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-165 | 59651-0165-30 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-166 | 59651-0166-30 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-167 | 59651-0167-30 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8028 | 50090-8028-01 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-534 | 16714-0534-01 |
| Emtricitabine And Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-312 | 72189-0312-03 |
| Emtricitabine And Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-741 | 69097-0741-02 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3831 | 68071-3831-03 |
Other NDCs under ANDA 203442
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 | NorthStar RxLLC | 16714-534 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-106 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8028 |