NDC 63020-535
Iclusig
Ponatinib Hydrochloride
Iclusig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Millennium Pharmaceuticals, Inc.. The primary component is Ponatinib Hydrochloride.
| Product ID | 63020-535_0277cb2e-ac32-4fd4-83a4-a3132984e934 |
| NDC | 63020-535 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Iclusig |
| Generic Name | Ponatinib Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-12-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203469 |
| Labeler Name | Millennium Pharmaceuticals, Inc. |
| Substance Name | PONATINIB HYDROCHLORIDE |
| Active Ingredient Strength | 15 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 63020-535-30
30 TABLET, FILM COATED in 1 BOTTLE (63020-535-30)
| Marketing Start Date | 2012-12-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 63020-535-60 [63020053560]
Iclusig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203469 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-12-14 |
NDC 63020-535-30 [63020053530]
Iclusig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203469 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-12-14 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PONATINIB HYDROCHLORIDE | 15 mg/1 |
OpenFDA Data
| SPL SET ID: | 16d804b6-4957-43ee-b18c-3b36ec37c5ac |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
NDC Crossover Matching brand name "Iclusig" or generic name "Ponatinib Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63020-533 | Iclusig | ponatinib hydrochloride |
| 63020-534 | Iclusig | ponatinib hydrochloride |
| 63020-535 | Iclusig | ponatinib hydrochloride |
| 63020-536 | Iclusig | ponatinib hydrochloride |
| 76189-533 | Iclusig | ponatinib hydrochloride |
| 76189-534 | Iclusig | ponatinib hydrochloride |
| 76189-535 | Iclusig | ponatinib hydrochloride |
Trademark Results [Iclusig]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICLUSIG 85254659 4324899 Live/Registered |
ARIAD Pharmaceuticals, Inc. 2011-03-01 |
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