Tenofovir Disoproxil Fumarate NDC 50268-758

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-758Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0758Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50268-758-12	50268075812	20 BLISTER PACK in 1 BOX (50268-758-12) / 1 TABLET in 1 BLISTER PACK (50268-758-11)Marketed from Mar 30, 2020

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: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090742
Marketing start: Mar 30, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers: Product ID 50268-758_47fc8e5e-ba97-0118-e063-6394a90ad45cSPL ID 47fc8e5e-ba97-0118-e063-6394a90ad45cSPL set ID a215f64c-84de-0649-e053-2a95a90a9d59RxCUI 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

N450268075812 followed by a unit qualifier and the quantity

Package 50268-0758-12. 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 Jan 9, 2026. 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. 1.2 C…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090742

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090742
Product	Strength	Form · route	Labeler	Product NDC
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	TabletOral	Strides Pharma Science Limited	64380-714