What is NDC 42291-800?

42291-800 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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?

19 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 42291-800

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-800Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0800Add 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
42291-800-30	42291080030	30 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)Marketed from Jan 10, 2019

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, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090636
Marketing start: Jan 10, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
Identifiers: Product ID 42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8SPL ID 4875aee4-c75a-ee36-e063-6394a90a9ce8SPL set ID 7f0bc342-0a0a-1d28-e053-2991aa0a28b9RxCUI 349251UNII OTT9J7900IUPC 0342291800304
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

N442291080030 followed by a unit qualifier and the quantity

Package 42291-0800-30. 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 15, 2026. 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. Tenofovir disoproxil fumarate tablets are 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. (1) Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-800

What is NDC 42291-800?: 42291-800 is the product NDC for Tenofovir Disoproxil Fumarate, Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by AvKARE. 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?: AvKARE, NDC labeler code 42291. 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?: 19 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	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
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-9729	63629-9729-01

All 20 Tenofovir Disoproxil Fumarate NDCs

Other NDCs under ANDA 090636

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

FDA NDC Directory listings under ANDA 090636
Product	Strength	Form · route	Labeler	Product NDC
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-9729
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	16714-820
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-535
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-361
Tenofovir Disoproxil Fumarate	Tenofovir disoproxil fumarate 300 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7202