tenofovir disoproxil fumarate NDC 0904-6821

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6821Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6821Add 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
0904-6821-04	00904682104	30 BLISTER PACK in 1 CARTON (0904-6821-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 26, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route: Oral
Labeler: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203232
Marketing start: Jan 26, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers: Product ID 0904-6821_cc508ae9-cfcb-48f7-b742-a0d3eec666b6SPL ID cc508ae9-cfcb-48f7-b742-a0d3eec666b6SPL set ID da78a5d3-f5c6-47fe-b593-3252704c225dRxCUI 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

N400904682104 followed by a unit qualifier and the quantity

Package 00904-6821-04. 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 Jul 18, 2025. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203232

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

FDA NDC Directory listings under ANDA 203232
Product	Strength	Form · route	Labeler	Product NDC
tenofovir disoproxil fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-096