Prescription drug · NDA
Pemazyre (Pemigatinib) NDC 50881-027
Pemigatinib 9 mg/1 · Tablet · Oral · Incyte Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50881-027-01 | 50881002701 | 14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01)Marketed from Apr 17, 2020 |
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)
- Pemazyre
- Generic name (nonproprietary)
- pemigatinib
- Active ingredients
- Pemigatinib — 9 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Incyte CorporationNDC labeler code 50881
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213736
- Marketing start
- Listing expires
- Other FDA classes
- Kinase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 50881-027_7ab778c9-5f92-4e53-bfe8-8db8d3bd3ef3SPL ID 7ab778c9-5f92-4e53-bfe8-8db8d3bd3ef3SPL set ID 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4RxCUI 2359334, 2359340, 2359342, 2359344, 2359346, 2359348UNII Y6BX7BL23K
- Pharmacologic class
- 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
N450881002701followed by a unit qualifier and the quantityPackage 50881-0027-01. 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 .
Indications (excerpt from the label)
PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1 , 2.1 ) 1.1 Cholangiocarcinom…
Excerpt only. Read the full label for complete information.
About NDC 50881-027
- What is NDC 50881-027?
- 50881-027 is the product NDC for Pemazyre (pemigatinib), Pemigatinib 9 mg/1 tablet, listed with the FDA by Incyte Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pemazyre (Pemigatinib).
- What is the active ingredient?
- Pemigatinib.
- Who is the labeler?
- Incyte Corporation, NDC labeler code 50881. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pemazyre?
- 2 other product NDCs are listed under this name. See all Pemazyre NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pemazyre products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pemazyrepemigatinib | Pemigatinib 4.5 mg/1 | TabletOral | Incyte Corporation | 50881-026 | 50881-0026-01 |
| Pemazyrepemigatinib | Pemigatinib 13.5 mg/1 | TabletOral | Incyte Corporation | 50881-028 | 50881-0028-01 |
Other NDCs under NDA 213736
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 |
|---|---|---|---|---|
| Pemazyrepemigatinib | Pemigatinib 4.5 mg/1 | TabletOral | Incyte Corporation | 50881-026 |
| Pemazyrepemigatinib | Pemigatinib 13.5 mg/1 | TabletOral | Incyte Corporation | 50881-028 |