NDC codes

FDA NDC Directory
Product NDC (as listed)61958-2002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61958-2002Add 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
61958-2002-16195820020130 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)Marketed from Apr 4, 2016
61958-2002-26195820020230 TABLET in 1 BLISTER PACK (61958-2002-2)Marketed from Jan 22, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Descovy
Generic name (nonproprietary)
emtricitabine and tenofovir alafenamide
Active ingredients
Emtricitabine — 200 mg/1Tenofovir alafenamide fumarate — 25 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208215
Marketing start
Listing expires
Other FDA classes
Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
Identifiers
Product ID 61958-2002_136e06f8-479d-4ecf-99f4-2a000ae61412SPL ID 136e06f8-479d-4ecf-99f4-2a000ae61412SPL set ID 06f66e98-e6ee-4538-9506-6c1282cc14c1RxCUI 1747691, 1747697, 2590641, 2590643UNII FWF6Q91TZO, G70B4ETF4S
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

N461958200201 followed by a unit qualifier and the quantity

Package 61958-2002-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

HIV-1 Treatment ( 1.1 ): DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg. for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor. HIV-1 PrEP ( 1.2 ): DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208215

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

FDA NDC Directory listings under NDA 208215
ProductStrengthForm · routeLabelerProduct NDC
Descovyemtricitabine and tenofovir alafenamideEmtricitabine 120 mg/1; Tenofovir alafenamide fumarate 15 mg/1TabletOralGilead Sciences, Inc.61958-2005

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