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 NDC11-digit (billing)PackageCopy
50268-758-12502680758125026807581220 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
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090742
Marketing start
Listing expires
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 . 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)

About NDC 50268-758

What is NDC 50268-758?
50268-758 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 300 mg/1 tablet, listed with the FDA by AvPAK. 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?
AvPAK, NDC labeler code 50268. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tenofovir Disoproxil Fumarate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-315571335-3155-0171335-3155-02
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralFlorida Pharmaceutical Products, LLC.71921-10571921-0105-33
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-36172789-0361-07
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralQuinn Pharmaceuticals69076-10569076-0105-03
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-236471335-2364-0171335-2364-02
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralAvKARE42291-80042291-0800-30
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-82016714-0820-01
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-720250090-7202-00
Tenofovir Disoproxil Fumaratetenofovir disoproxil fumarate tabletsTenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralChartwell RX, LLC.62135-46662135-0466-30
tenofovir disoproxil fumarateTenofovir disoproxil fumarate 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-682100904-6821-04

All 19 Tenofovir Disoproxil Fumarate NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1TabletOralStrides Pharma Science Limited64380-714

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