NDC 76189-534
Iclusig
Ponatinib Hydrochloride
Iclusig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ariad Pharmaceuticals, Inc.. The primary component is Ponatinib Hydrochloride.
| Product ID | 76189-534_618b6b2f-ca86-4839-9170-e873e279d592 |
| NDC | 76189-534 |
| 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 End Date | 2020-07-26 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203469 |
| Labeler Name | ARIAD Pharmaceuticals, Inc. |
| Substance Name | PONATINIB HYDROCHLORIDE |
| Active Ingredient Strength | 45 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
Packaging
NDC 76189-534-90
90 TABLET, FILM COATED in 1 BOTTLE (76189-534-90)
| Marketing Start Date | 2012-12-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 76189-534-30 [76189053430]
Iclusig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203469 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-12-14 |
| Marketing End Date | 2020-07-26 |
NDC 76189-534-90 [76189053490]
Iclusig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA203469 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-12-14 |
| Marketing End Date | 2020-07-26 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PONATINIB HYDROCHLORIDE | 45 mg/1 |
OpenFDA Data
| SPL SET ID: | 807f988e-117b-4497-934d-73aa78baac71 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
- 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.