NDC codes

FDA NDC Directory
Product NDC (as listed)71921-105Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71921-0105Add 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
71921-105-33719210105337192101053330 TABLET, COATED in 1 BOTTLE, PLASTIC (71921-105-33)Marketed from Nov 26, 2025

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, Coated
Route
Oral
Labeler
Florida Pharmaceutical Products, LLC.NDC labeler code 71921
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209498
Marketing start
Listing expires
Other FDA classes
Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers
Product ID 71921-105_79278443-b9ee-4db6-ac15-a3d12b359eb0SPL ID 79278443-b9ee-4db6-ac15-a3d12b359eb0SPL set ID 0c7d72d6-bf80-49e0-921c-20169e87e62fRxCUI 349251UNII OTT9J7900IUPC 0371921105335
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

N471921010533 followed by a unit qualifier and the quantity

Package 71921-0105-33. 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 35 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 35 kg. ( 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 wei…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71921-105

What is NDC 71921-105?
71921-105 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 300 mg/1 tablet, coated, listed with the FDA by Florida Pharmaceutical Products, LLC.. 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?
Florida Pharmaceutical Products, LLC., NDC labeler code 71921. 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, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-36172789-0361-07
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1TabletOralAvPAK50268-75850268-0758-12
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 209498

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

FDA NDC Directory listings under ANDA 209498
ProductStrengthForm · routeLabelerProduct NDC
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralQuinn Pharmaceuticals69076-105
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-2364
Tenofovir Disoproxil FumarateTenofovir disoproxil fumarate 300 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-3155

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