Prescription drug · ANDA
Emtricitabine and tenofovir disoproxil fumarate NDC 70771-1622
Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70771-1622Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1622Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1622-3 | 7077116220370771162203 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1622-3)Marketed from Jul 1, 2021 | |
| 70771-1622-4 | 7077116220470771162204 | 10 BLISTER PACK in 1 CARTON (70771-1622-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1622-2)Marketed from Jul 1, 2021 | |
| 70771-1622-9 | 7077116220970771162209 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1622-9)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
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- 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 70771-1622_8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6SPL ID 8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6SPL set ID a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3RxCUI 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
N470771162203followed by a unit qualifier and the quantityPackage 70771-1622-03. 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 .
About NDC 70771-1622
- What is NDC 70771-1622?
- 70771-1622 is the product NDC for Emtricitabine and tenofovir disoproxil fumarate, Emtricitabine 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 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 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 133 mg/1; Tenofovir disoproxil fumarate 200 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1365 |
| 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 167 mg/1; Tenofovir disoproxil fumarate 250 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1366 |
| Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine 200 mg/1; Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1367 |