What is NDC 65862-819?

65862-819 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 200 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tenofovir Disoproxil Fumarate NDC 65862-819

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-819Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0819Add 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
65862-819-03	6586208190365862081903	3 BLISTER PACK in 1 CARTON (65862-819-03) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 26, 2018
65862-819-30	6586208193065862081930	30 TABLET, FILM COATED in 1 BOTTLE (65862-819-30)Marketed from Jan 26, 2018

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 — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090647
Marketing start: Jan 26, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers: Product ID 65862-819_ab772f55-3f84-41df-a84f-3a7035602cfdSPL ID ab772f55-3f84-41df-a84f-3a7035602cfdSPL set ID a75c6be8-3719-4bb3-8a9e-06e5254d2a82RxCUI 349251, 1243227, 1243324, 1243328UNII OTT9J7900IUPC 0365862820303, 0365862819307
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

N465862081903 followed by a unit qualifier and the quantity

Package 65862-0819-03. 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 Jun 7, 2024. 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 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 age and olde…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-819

What is NDC 65862-819?: 65862-819 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 200 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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
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 Fumaratetenofovir disoproxil fumarate tablets	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC.	62135-466	62135-0466-30

All 19 Tenofovir Disoproxil Fumarate NDCs

Other NDCs under ANDA 090647

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

FDA NDC Directory listings under ANDA 090647
Product	Strength	Form · route	Labeler	Product NDC
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 150 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-818
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 250 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-820