PEMAZYRE
- Product NDC
- 50881-027
- 11-digit product format
- 508810027
- Labeler code
- 50881
- Product ID
- 50881-027_741de3ad-f255-4da5-b43a-60a99caf4137
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pemigatinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Incyte Corporation
- Application
- NDA213736
- Marketing category
- NDA
- Marketing start
- 2020-04-17
- Substance
- PEMIGATINIB
- Active strength
- 9 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PEMAZYRE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMIGATINIB | 9 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y6BX7BL23K |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50881-027-01 | PEMAZYRE | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50881-027 | PEMAZYRE (PEMIGATINIB) TABLET [INCYTE CORPORATION] | 11 | Current NDC, Legacy NDC, 1 package rows | 20230615_9e1f2222-1d89-4e63-989c-ccebe2ab1eb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50881-027-01 | 50881002701 | 14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01) | 14 tablet | 2020-04-17 | 0000-00-00 | No | No | Current |