What is NDC 42385-999?

42385-999 is the product NDC for Rilpivirine, Rilpivirine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rilpivirine?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rilpivirine NDC 42385-999 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-999Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0999Add 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
42385-999-30	42385099930	30 TABLET, FILM COATED in 1 BOTTLE (42385-999-30)Marketed from Jul 10, 2026
42385-999-31	42385099931	30 TABLET, FILM COATED in 1 BOTTLE (42385-999-31)Marketed from Jul 10, 2026

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): Rilpivirine
Generic name (nonproprietary): rilpivirine
Active ingredients: Rilpivirine hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Laurus Labs LimitedNDC labeler code 42385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219788
Marketing start: Jul 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 42385-999_dadbf50d-6b7d-4fb5-bd9f-7769b048e764SPL ID dadbf50d-6b7d-4fb5-bd9f-7769b048e764SPL set ID dadbf50d-6b7d-4fb5-bd9f-7769b048e764RxCUI 1102273UNII 212WAX8KDD
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

N442385099930 followed by a unit qualifier and the quantity

Package 42385-0999-30. 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 15, 2026.

Indications (excerpt from the label)

Rilpivirine tablets 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 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 ). Limitations of Use: • More rilpivirine 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 rilpivirine treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 , 14 ) Rilpivirine tablets are indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42385-999

What is NDC 42385-999?: 42385-999 is the product NDC for Rilpivirine, Rilpivirine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rilpivirine.
What is the active ingredient?: Rilpivirine hydrochloride.
Who is the labeler?: Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rilpivirine?: 1 other product NDC are listed under this name. See all Rilpivirine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Rilpivirine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rilpivirine	Rilpivirine hydrochloride 25 mg/1	Tablet, Film coatedOral	Somerset Therapeutics, LLC	70069-848	70069-0848-30