DARZALEX
- Product NDC
- 57894-502
- 11-digit product format
- 578940502
- Labeler code
- 57894
- Product ID
- 57894-502_7a931e23-16ed-4112-a593-6c1a696cd4aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daratumumab
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA761036
- Marketing category
- BLA
- Marketing start
- 2015-11-16
- Substance
- DARATUMUMAB
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DARZALEX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DARATUMUMAB | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Z63YK6E0E |
| Rxcui | 1721951, 1721956, 1726439, 1726440 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 57894-502-05 | 2021-09-10 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-05 | 2021-09-10 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-20 | 2021-09-10 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-20 | 2021-09-10 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-05 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-05 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-20 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
| 57894-502-20 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-123f-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-502-05 | DARZALEX | 5 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 5 | | 43 |
| 57894-502-05 | DARZALEX | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 43 |
| 57894-502-20 | DARZALEX | 20 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 20 | | 43 |
| 57894-502-20 | DARZALEX | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 43 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Daratumumab | ACTIVE INGREDIENT | 4Z63YK6E0E | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
| Daratumumab | ACTIVE MOIETY | 4Z63YK6E0E | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-502 | DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE DARZALEX IV (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 40 | Current NDC, Legacy NDC, 4 package rows | 20250417_a4d0efe9-5e54-467e-9eb4-56fa7d53b60b.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 |
|---|
| 57894-502-05 | 57894050205 | 1 VIAL in 1 CARTON (57894-502-05) / 5 mL in 1 VIAL | 1 vial | 2015-11-16 | 2026-10-31 | No | No | Current |
| 57894-502-20 | 57894050220 | 1 VIAL in 1 CARTON (57894-502-20) / 20 mL in 1 VIAL | 1 vial | 2015-11-16 | 2026-11-30 | No | No | Current |