SCEMBLIX
- Product NDC
- 0078-1098
- 11-digit product format
- 000781098
- Labeler code
- 0078
- Product ID
- 0078-1098_e187165a-eb84-4ee5-98b8-d4e777ec7b4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- asciminib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA215358
- Marketing category
- NDA
- Marketing start
- 2021-10-29
- Substance
- ASCIMINIB HYDROCHLORIDE
- Active strength
- 40 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SCEMBLIX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASCIMINIB HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C5U34S9XFV |
| Rxcui | 2584320, 2584326, 2584328, 2584330, 2680278, 2680280 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-1098-05 | SCEMBLIX | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 12 |
| 0078-1098-20 | SCEMBLIX | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 12 |
| 0078-1098-30 | SCEMBLIX | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 12 |
| 0078-1098-94 | SCEMBLIX | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-1098 | SCEMBLIX (ASCIMINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241101_e33001e7-3650-42b1-ae56-cddb5c43aa2b.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 |
|---|
| 0078-1098-05 | 00078109805 | 60 in 1 BOTTLE | | | | | | Historical |
| 0078-1098-20 | 00078109820 | 60 TABLET, FILM COATED in 1 BOTTLE (0078-1098-20) | | 2021-10-29 | 0000-00-00 | No | No | Current |
| 0078-1098-30 | 00078109830 | 5 BOTTLE in 1 CARTON (0078-1098-30) > 60 TABLET, FILM COATED in 1 BOTTLE (0078-1098-05) | 5 bottle | 2021-10-29 | 0000-00-00 | No | No | Current |
| 0078-1098-94 | 00078109894 | 14 TABLET, FILM COATED in 1 BOTTLE (0078-1098-94) | | 2021-10-29 | 0000-00-00 | Yes | No | Current |