Prescription drug · ANDA
Emtricitabine and Tenofovir Disoproxil Fumarate NDC 42385-953
Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Film coated · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-953-30 | 4238509533042385095330 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-953-30)Marketed from Jul 26, 2019 | |
| 42385-953-90 | 4238509539042385095390 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-953-90)Marketed from Jul 26, 2019 |
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, Film coated
- Route
- Oral
- Labeler
- Laurus Labs LimitedNDC labeler code 42385
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212114
- 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 42385-953_bf69c830-aa6f-4813-8421-6b3bd689086dSPL ID bf69c830-aa6f-4813-8421-6b3bd689086dSPL set ID 4a7ccbbf-da20-4012-9717-31c411efb3fbRxCUI 476556UNII G70B4ETF4S, OTT9J7900IUPC 0342385953305
- 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
N442385095330followed by a unit qualifier and the quantityPackage 42385-0953-30. 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 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.
About NDC 42385-953
- What is NDC 42385-953?
- 42385-953 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 Laurus Labs Limited. It has 2 package NDCs, 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?
- Laurus Labs Limited, NDC labeler code 42385. 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 | NuCare Pharmaceuticals, Inc. | 68071-3695 | 68071-3695-03 |
| 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 |
Other NDCs under ANDA 212114
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 | Major Pharmaceuticals | 0904-7172 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6494 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3986 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2650 |