Prescription drug · NDA
Rinvoq (Upadacitinib) NDC 0074-2306
Upadacitinib 15 mg/1 · Tablet, Extended release · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-2306-30 | 00074230630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-30)Marketed from Aug 16, 2019 | |
| 0074-2306-70 | 00074230670 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-70)Marketed from Aug 16, 2019 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Rinvoq
- Generic name (nonproprietary)
- upadacitinib
- Active ingredients
- Upadacitinib — 15 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211675
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0074-2306_e17266e5-c861-46bf-9756-6447566101beSPL ID e17266e5-c861-46bf-9756-6447566101beSPL set ID 2966aec7-2ef0-923c-d8ff-fe1a957bf095RxCUI 2196894, 2196900, 2590051, 2590054, 2596957, 2596960, 2681015, 2681019UNII 4RA0KN46E0
- Pharmacologic class
- Janus Kinase 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
N400074230630followed by a unit qualifier and the quantityPackage 00074-2306-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.1 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.2 ) Limitation s of Use RINVOQ/RINVOQ LQ …
Excerpt only. Read the full label for complete information.
About NDC 0074-2306
- What is NDC 0074-2306?
- 0074-2306 is the product NDC for Rinvoq (upadacitinib), Upadacitinib 15 mg/1 tablet, extended release, listed with the FDA by AbbVie Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rinvoq (Upadacitinib).
- What is the active ingredient?
- Upadacitinib.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rinvoq?
- 3 other product NDCs are listed under this name. See all Rinvoq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rinvoq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rinvoqupadacitinib | Upadacitinib 1 mg/mL | SolutionOral | AbbVie Inc. | 0074-2320 | 00074-2320-0100074-2320-70 |
| Rinvoqupadacitinib | Upadacitinib 45 mg/1 | Tablet, Extended releaseOral | AbbVie Inc. | 0074-1043 | 00074-1043-1400074-1043-28 |
| Rinvoqupadacitinib | Upadacitinib 30 mg/1 | Tablet, Extended releaseOral | AbbVie Inc. | 0074-2310 | 00074-2310-2000074-2310-30 |
Other NDCs under NDA 211675
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Rinvoqupadacitinib | Upadacitinib 30 mg/1 | Tablet, Extended releaseOral | AbbVie Inc. | 0074-2310 |
| Rinvoqupadacitinib | Upadacitinib 45 mg/1 | Tablet, Extended releaseOral | AbbVie Inc. | 0074-1043 |