Iclusig
- Product NDC
- 63020-536
- 11-digit product format
- 630200536
- Labeler code
- 63020
- Product ID
- 63020-536_1987d030-31ce-4d26-9871-0a3e7ee4e522
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ponatinib hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA203469
- Marketing category
- NDA
- Marketing start
- 2021-01-11
- Substance
- PONATINIB HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase 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
- Iclusig
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PONATINIB HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 96R6PU3D8J |
| Rxcui | 1364352, 1364358, 1364360, 1364362, 1726637, 1726639, 2473040, 2473042 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63020-536-30 | Iclusig | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63020-536 | ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 17 | Current NDC, Legacy NDC, 1 package rows | 20241222_16d804b6-4957-43ee-b18c-3b36ec37c5ac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63020-536-30 | 63020053630 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-536-30) | 2021-01-11 | 0000-00-00 | No | No | Current |