Emtricitabine and tenofovir disoproxil fumarate NDC 16714-534

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-534Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0534Add 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
16714-534-01	16714053401	30 TABLET, FILM COATED in 1 BOTTLE (16714-534-01)Marketed from Mar 9, 2022

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): Emtricitabine and tenofovir disoproxil fumarate
Generic name (nonproprietary): emtricitabine and tenofovir disoproxil fumarate
Active ingredients: Emtricitabine — 200 mg/1Tenofovir disoproxil fumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NorthStar RxLLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203442
Marketing start: Mar 9, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
Identifiers: Product ID 16714-534_1fab5d61-9784-4a57-9895-cb797fae1400SPL ID 1fab5d61-9784-4a57-9895-cb797fae1400SPL set ID fbbc7b73-eddf-40b5-8ebb-7b3d9c42dba6RxCUI 476556UNII G70B4ETF4S, OTT9J7900IUPC 0316714534015
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

N416714053401 followed by a unit qualifier and the quantity

Package 16714-0534-01. 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 25, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

HIV-1 Treatment ( 1.1 ) Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): • Emtricitabine and Tenofovir Disoproxil Fumarate is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initi…

Excerpt only. Read the full label for complete information.

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