What is NDC 61958-1101?

61958-1101 is the product NDC for Complera, Emtricitabine 200 mg/1 + 2 more ingredients tablet, film coated, 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?

Complera (Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate).

What is the active ingredient?

Emtricitabine, Rilpivirine hydrochloride, Tenofovir disoproxil 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 Complera?

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.

Complera NDC 61958-1101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-1101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-1101Add 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
61958-1101-1	6195811010161958110101	30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)Marketed from Aug 10, 2011

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): Complera
Generic name (nonproprietary): emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Active ingredients: Emtricitabine — 200 mg/1Rilpivirine hydrochloride — 25 mg/1Tenofovir disoproxil fumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Gilead Sciences, Inc.NDC labeler code 61958
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202123
Marketing start: Aug 10, 2011
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 61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6SPL ID 21d7850d-11ea-43cc-84a5-0dae02a19ce6SPL set ID d637cfab-f1e8-4eb3-a1b3-f85ca3bec612RxCUI 1147334, 1147337UNII G70B4ETF4S, 212WAX8KDD, OTT9J7900I
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

N461958110101 followed by a unit qualifier and the quantity

Package 61958-1101-01. 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 16, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

COMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA [see Microbiology (12.4) and Clinical Studies (14) ] . COMPLERA, a combination of two nucleoside analog HIV-1 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61958-1101

What is NDC 61958-1101?: 61958-1101 is the product NDC for Complera, Emtricitabine 200 mg/1 + 2 more ingredients tablet, film coated, 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?: Complera (Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate).
What is the active ingredient?: Emtricitabine, Rilpivirine hydrochloride, Tenofovir disoproxil 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 Complera?: 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.