Simulect
- Product NDC
- 0078-0393
- 11-digit product format
- 000780393
- Labeler code
- 0078
- Product ID
- 0078-0393_3a12b631-15b1-4b4a-a018-692037cc4709
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- basiliximab
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- BLA103764
- Marketing category
- BLA
- Marketing start
- 1998-05-12
- Substance
- BASILIXIMAB
- Active strength
- 10 mg/2.5mL
- Pharmacologic classes
- Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simulect
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BASILIXIMAB | 10 mg/2.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9927MT646M |
| Rxcui | 1656643, 1656646, 1656648, 1656650 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0393-61 | Simulect | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 18 |
| 0078-0393-61 | Simulect | 2.5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, FOR SOLUTION | 2.5 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BASILIXIMAB | ACTIVE INGREDIENT | 9927MT646M | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| BASILIXIMAB | ACTIVE MOIETY | 9927MT646M | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0393 | SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250122_1af01887-b69d-444b-91ed-ebfe12784440.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 |
|---|
| 0078-0393-61 | 00078039361 | 1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) / 2.5 mL in 1 VIAL, SINGLE-USE | 1998-05-12 | 0000-00-00 | No | No | Current |