Prescription drug · ANDA
Tenofovir Disoproxil Fumarate NDC 71335-2364
Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2364-1 | 71335236401 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-1)Marketed from Apr 30, 2024 | |
| 71335-2364-2 | 71335236402 | 15 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-2)Marketed from Apr 30, 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)
- Tenofovir Disoproxil Fumarate
- Generic name (nonproprietary)
- tenofovir disoproxil fumarate
- Active ingredients
- Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209498
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 71335-2364_89290f33-955e-45fc-a481-ca4650cd125bSPL ID 89290f33-955e-45fc-a481-ca4650cd125bSPL set ID 3285f345-e58d-4831-a6a8-31094c8c546dRxCUI 349251UNII 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
N471335236401followed by a unit qualifier and the quantityPackage 71335-2364-01. 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)
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 35 kg. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older wei…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209498
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 |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Quinn Pharmaceuticals | 69076-105 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-3155 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Florida Pharmaceutical Products, LLC. | 71921-105 |