Prescription drug · ANDA
Tenofovir Disoproxil Fumarate (Tenofovir disoproxil fumarate tablets) NDC 62135-466
Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-466-30 | 6213504663062135046630 | 30 TABLET, FILM COATED in 1 BOTTLE (62135-466-30)Marketed from Jun 30, 2022 |
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 tablets
- Active ingredients
- Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Chartwell RX, LLC.NDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206481
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 62135-466_ef9f6879-525d-e5a6-e053-2a95a90ad8beSPL ID ef9f6879-525d-e5a6-e053-2a95a90ad8beSPL set ID 9cf11bd3-01b9-4ac8-96cc-55d57998b51dRxCUI 349251UNII OTT9J7900IUPC 0362135466305
- 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
N462135046630followed by a unit qualifier and the quantityPackage 62135-0466-30. 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)
Tenofovir disoproxil fumarate tablets are 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 2 years and older weighing at least 10 kg. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are 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…
Excerpt only. Read the full label for complete information.
About NDC 62135-466
- What is NDC 62135-466?
- 62135-466 is the product NDC for Tenofovir Disoproxil Fumarate (tenofovir disoproxil fumarate tablets), Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tenofovir Disoproxil Fumarate (TENOFOVIR DISOPROXIL FUMARATE Tablets).
- What is the active ingredient?
- Tenofovir disoproxil fumarate.
- Who is the labeler?
- Chartwell RX, LLC., NDC labeler code 62135. 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 fumarate | Tenofovir disoproxil fumarate 300 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6821 | 00904-6821-04 |