What is NDC 59676-280?

59676-280 is the product NDC for Edurant Ped (rilpivirine hydrochloride), Rilpivirine hydrochloride 2.5 mg/1 tablet, for suspension, listed with the FDA by Janssen Products, LP. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Edurant Ped (Rilpivirine hydrochloride).

Janssen Products, LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Edurant Ped?

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.

Edurant Ped NDC 59676-280 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59676-280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59676-0280Add 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
59676-280-90	59676028090	9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)Marketed from Mar 15, 2024

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): Edurant Ped
Generic name (nonproprietary): rilpivirine hydrochloride
Active ingredients: Rilpivirine hydrochloride — 2.5 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Janssen Products, LPNDC labeler code 59676
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219016
Marketing start: Mar 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43SPL ID 3d6d0fcc-0b62-b76b-e063-6294a90aea43SPL set ID 03880372-2c68-45c6-a53a-f420c49541d6RxCUI 1102273, 1102277, 2678244, 2678248UNII 212WAX8KDDUPC 0359676278016
Pharmacologic class: Human Immunodeficiency Virus 1 Non-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

N459676028090 followed by a unit qualifier and the quantity

Package 59676-0280-90. 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 Aug 28, 2025.

Indications (excerpt from the label)

EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 ). Limitations of Use: More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 , 14 ) EDURANT is indicated in combination wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59676-280

What is NDC 59676-280?: 59676-280 is the product NDC for Edurant Ped (rilpivirine hydrochloride), Rilpivirine hydrochloride 2.5 mg/1 tablet, for suspension, listed with the FDA by Janssen Products, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Edurant Ped (Rilpivirine hydrochloride).
What is the active ingredient?: Rilpivirine hydrochloride.
Who is the labeler?: Janssen Products, LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Edurant Ped?: 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.

Edurant Ped (Rilpivirine hydrochloride) NDC 59676-280