Prescription drug · ANDA
Rilpivirine NDC 70069-848
Rilpivirine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-848-30 | 7006908483070069084830 | 30 TABLET, FILM COATED in 1 BOTTLE (70069-848-30)Marketed from Jan 30, 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
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218798
- Marketing start
- Listing expires
- Other FDA classes
- Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 70069-848_8d833cc1-60b6-4e31-aff3-2958b8f93d1fSPL ID 8d833cc1-60b6-4e31-aff3-2958b8f93d1fSPL set ID fb109de9-d88d-4405-8dd6-d458cbc387d1RxCUI 1102273UNII 212WAX8KDDUPC 0370069848302
- 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
N470069084830followed by a unit qualifier and the quantityPackage 70069-0848-30. 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 .
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 indicated in…
Excerpt only. Read the full label for complete information.
About NDC 70069-848
- What is NDC 70069-848?
- 70069-848 is the product NDC for Rilpivirine, Rilpivirine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, 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?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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.
Related NDCs: other Rilpivirine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rilpivirine | Rilpivirine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-999 | 42385-0999-3042385-0999-31 |