What is NDC 61958-2101?

61958-2101 is the product NDC for Odefsey, Emtricitabine 200 mg/1 + 2 more ingredients tablet, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Odefsey (Emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide).

What is the active ingredient?

Emtricitabine, Rilpivirine hydrochloride, Tenofovir alafenamide fumarate.

Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Odefsey?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Odefsey NDC 61958-2101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-2101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-2101Add 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
61958-2101-1	6195821010161958210101	30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)Marketed from Mar 1, 2016

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): Odefsey
Generic name (nonproprietary): emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
Active ingredients: Emtricitabine — 200 mg/1Rilpivirine hydrochloride — 25 mg/1Tenofovir alafenamide fumarate — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Gilead Sciences, Inc.NDC labeler code 61958
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208351
Marketing start: Mar 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
Identifiers: Product ID 61958-2101_130b8bbc-f660-40ff-831c-139734f90b99SPL ID 130b8bbc-f660-40ff-831c-139734f90b99SPL set ID ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5RxCUI 1741733, 1741739UNII G70B4ETF4S, 212WAX8KDD, FWF6Q91TZO
Pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus 1 Non-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

N461958210101 followed by a unit qualifier and the quantity

Package 61958-2101-01. 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 Dec 2, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

ODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY [see Microbiology (12.4) and Clinical Studies (14) ]. ODEFSEY is a three-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleosi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61958-2101

What is NDC 61958-2101?: 61958-2101 is the product NDC for Odefsey, Emtricitabine 200 mg/1 + 2 more ingredients tablet, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Odefsey (Emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide).
What is the active ingredient?: Emtricitabine, Rilpivirine hydrochloride, Tenofovir alafenamide fumarate.
Who is the labeler?: Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Odefsey?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.