MARGENZA
- Product NDC
- 74527-022
- 11-digit product format
- 745270022
- Labeler code
- 74527
- Product ID
- 74527-022_97ee3be5-cd7f-45d4-85c7-b48ad596e837
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- margetuximab-cmkb
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- MacroGenics, Inc
- Application
- BLA761150
- Marketing category
- BLA
- Marketing start
- 2021-01-15
- Substance
- MARGETUXIMAB
- Active strength
- 25 mg/mL
- Pharmacologic classes
- HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MARGENZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MARGETUXIMAB | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K911R84KEW |
| Rxcui | 2474028, 2474033 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 74527-022-01 | MARGENZA | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 6 |
| 74527-022-02 | MARGENZA | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 6 |
| 74527-022-03 | MARGENZA | 4 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 74527-022 | MARGENZA (MARGETUXIMAB-CMKB) INJECTION, SOLUTION, CONCENTRATE [MACROGENICS, INC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250125_e97a5872-eabf-463b-8f4c-5b5aed9c7bf0.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 |
|---|
| 74527-022-01 | 74527002201 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 74527-022-02 | 74527002202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-02) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01) | | 2021-01-15 | 0000-00-00 | No | No | Current |
| 74527-022-03 | 74527002203 | 4 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-03) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01) | | 2021-01-15 | 0000-00-00 | No | No | Current |