Unituxin
- Product NDC
- 66302-014
- 11-digit product format
- 663020014
- Labeler code
- 66302
- Product ID
- 66302-014_b841106b-07b0-473b-9da9-a91b4363e3b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DINUTUXIMAB
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- United Therapeutics Corporation
- Application
- BLA125516
- Marketing category
- BLA
- Marketing start
- 2015-03-10
- Substance
- DINUTUXIMAB
- Active strength
- 3.5 mg/mL
- Pharmacologic classes
- Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed 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
- Unituxin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DINUTUXIMAB | 3.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7SQY4ZUD30 |
| Rxcui | 1606278, 1606283 |
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 |
|---|
| 66302-014-01 | Unituxin | 1 in 1 BOX | INJECTION | 1 | | 13 |
| 66302-014-01 | Unituxin | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66302-014 | UNITUXIN (DINUTUXIMAB) INJECTION [UNITED THERAPEUTICS CORPORATION] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241222_d66bdf0d-9d65-45de-ae5b-a58617c27492.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 |
|---|
| 66302-014-01 | 66302001401 | 1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2015-03-10 | 0000-00-00 | No | No | Current |