BENLYSTA
- Product NDC
- 49401-101
- 11-digit product format
- 494010101
- Labeler code
- 49401
- Product ID
- 49401-101_379d7f58-8f17-44b3-8336-6fe8ef015aed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- belimumab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- GlaxoSmithKline LLC
- Application
- BLA125370
- Marketing category
- BLA
- Marketing start
- 2011-03-10
- Substance
- BELIMUMAB
- Active strength
- 120 mg/1.5mL
- Pharmacologic classes
- B Lymphocyte Stimulator-directed Antibody Interactions [MoA], B Lymphocyte Stimulator-specific Inhibitor [EPC], Decreased B Lymphocyte Activation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BENLYSTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BELIMUMAB | 120 mg/1.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 73B0K5S26A |
| Rxcui | 1656395, 1656398, 1656400, 1656402, 1939296, 1939299, 1939346, 1939348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49401-101-01 | BENLYSTA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 37 |
| 49401-101-01 | BENLYSTA | 1.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1.5 | | 37 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BELIMUMAB | ACTIVE INGREDIENT | 73B0K5S26A | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.] | 12 | |
| BELIMUMAB | ACTIVE MOIETY | 73B0K5S26A | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.] | 12 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.] | 12 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.] | 12 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.] | 12 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49401-101 | BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC] | 34 | Current NDC, Legacy NDC, 2 package rows | 20241220_2fa3c528-1777-4628-8a55-a69dae2381a3.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 |
|---|
| 49401-101-01 | 49401010101 | 1 VIAL in 1 CARTON (49401-101-01) / 1.5 mL in 1 VIAL | 1 vial | 2011-03-10 | 0000-00-00 | No | No | Current |