Prescription drug · ANDA
Tenofovir Disoproxil Fumarate NDC 72789-361
Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-361-07 | 72789036107 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-361-07)Marketed from Oct 26, 2023 |
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)
- Tenofovir Disoproxil Fumarate
- Generic name (nonproprietary)
- tenofovir disoproxil fumarate
- Active ingredients
- Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090636
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 72789-361_40bb71ff-3881-bd53-e063-6394a90a38efSPL ID 40bb71ff-3881-bd53-e063-6394a90a38efSPL set ID 08a30772-02fc-4f63-e063-6394a90afd43RxCUI 349251UNII OTT9J7900IUPC 0372789361079
- 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
N472789036107followed by a unit qualifier and the quantityPackage 72789-0361-07. 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 tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. • Tenofovir disoproxil fumarate tablets are 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. (1) • Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 yea…
Excerpt only. Read the full label for complete information.
About NDC 72789-361
- What is NDC 72789-361?
- 72789-361 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tenofovir Disoproxil Fumarate.
- What is the active ingredient?
- Tenofovir disoproxil fumarate.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tenofovir Disoproxil Fumarate?
- 19 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-3155 | 71335-3155-0171335-3155-02 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Florida Pharmaceutical Products, LLC. | 71921-105 | 71921-0105-33 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | TabletOral | AvPAK | 50268-758 | 50268-0758-12 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2364 | 71335-2364-0171335-2364-02 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, CoatedOral | Quinn Pharmaceuticals | 69076-105 | 69076-0105-03 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-800 | 42291-0800-30 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-820 | 16714-0820-01 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7202 | 50090-7202-00 |
| Tenofovir Disoproxil Fumaratetenofovir disoproxil fumarate tablets | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC. | 62135-466 | 62135-0466-30 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9729 | 63629-9729-01 |
Other NDCs under ANDA 090636
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, Film coatedOral | Bryant Ranch Prepack | 63629-9729 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-800 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-820 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-535 |
| Tenofovir Disoproxil Fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7202 |