NDC 57962-420
Imbruvica
Ibrutinib
Imbruvica is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmacyclics Llc. The primary component is Ibrutinib.
| Product ID | 57962-420_0d02fa60-b63e-4a9d-9db2-0138cd052b33 |
| NDC | 57962-420 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Imbruvica |
| Generic Name | Ibrutinib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-02-16 |
| Marketing Category | NDA / NDA |
| Application Number | NDA210563 |
| Labeler Name | Pharmacyclics LLC |
| Substance Name | IBRUTINIB |
| Active Ingredient Strength | 420 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 57962-420-28
1 BLISTER PACK in 1 CARTON (57962-420-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK
| Marketing Start Date | 2018-02-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 57962-420-71 [57962042071]
Imbruvica TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA210563 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-06 |
NDC 57962-420-28 [57962042028]
Imbruvica TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA210563 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-02-16 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IBRUTINIB | 420 mg/1 |
OpenFDA Data
| SPL SET ID: | 0dfd0279-ff17-4ea9-89be-9803c71bab44 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
NDC Crossover Matching brand name "Imbruvica" or generic name "Ibrutinib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 57962-007 | Imbruvica | Ibrutinib |
| 57962-014 | Imbruvica | Ibrutinib |
| 57962-070 | Imbruvica | Ibrutinib |
| 57962-140 | Imbruvica | Ibrutinib |
| 57962-280 | Imbruvica | Imbruvica |
| 57962-420 | Imbruvica | Imbruvica |
| 57962-560 | Imbruvica | Imbruvica |
Trademark Results [Imbruvica]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMBRUVICA 86012748 not registered Dead/Abandoned |
Pharmacyclics, Inc. 2013-07-17 |
 IMBRUVICA 86007097 4523481 Live/Registered |
Pharmacyclics, Inc. 2013-07-10 |
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