Prescription drug · ANDA
Tenofovir disoproxil fumarate NDC 69097-533
Tenofovir disoproxil fumarate 300 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-533-02 | 6909705330269097053302 | 30 TABLET in 1 BOTTLE (69097-533-02)Marketed from Jan 26, 2018 | |
| 69097-533-15 | 6909705331569097053315 | 1000 TABLET in 1 BOTTLE (69097-533-15)Marketed from Jan 26, 2018 |
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
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078800
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 69097-533_cee87535-9401-4baf-920c-7184d8959c09SPL ID cee87535-9401-4baf-920c-7184d8959c09SPL set ID de27413a-6579-4586-80dc-39c712652952RxCUI 349251UNII OTT9J7900IUPC 0369097533021
- 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
N469097053302followed by a unit qualifier and the quantityPackage 69097-0533-02. 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 10 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. ( 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 weighing at least 10 kg. 1…
Excerpt only. Read the full label for complete information.
About NDC 69097-533
- What is NDC 69097-533?
- 69097-533 is the product NDC for Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate 300 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, 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?
- Cipla USA Inc., NDC labeler code 69097. 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?
- 18 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 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-361 | 72789-0361-07 |
| 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 | Quinn Pharmaceuticals | 69076-105 | 69076-0105-03 |
| 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, 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 |