YERVOY
- Product NDC
- 0003-2328
- 11-digit product format
- 000032328
- Labeler code
- 0003
- Product ID
- 0003-2328_ecc3bf01-2632-4c2e-85aa-e34da43d25f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ipilimumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- BLA125377
- Marketing category
- BLA
- Marketing start
- 2011-03-25
- Substance
- IPILIMUMAB
- Active strength
- 5 mg/mL
- Pharmacologic classes
- CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- YERVOY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IPILIMUMAB | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T8C155666 |
| Rxcui | 1657005, 1657007, 1657012, 1657013 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-2328-22 | YERVOY | 1 in 1 CARTON | INJECTION | 1 | | 45 |
| 0003-2328-22 | YERVOY | 40 mL in 1 VIAL, SINGLE-USE | INJECTION | 40 | | 45 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IPILIMUMAB | ACTIVE INGREDIENT | 6T8C155666 | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| IPILIMUMAB | ACTIVE MOIETY | 6T8C155666 | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| PENTETIC ACID | INACTIVE INGREDIENT | 7A314HQM0I | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| TROMETHAMINE HYDROCHLORIDE | INACTIVE INGREDIENT | 383V75M34E | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-2328 | YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 44 | Current NDC, Legacy NDC, 2 package rows | 20250426_2265ef30-253e-11df-8a39-0800200c9a66.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 |
|---|
| 0003-2328-22 | 00003232822 | 1 VIAL, SINGLE-USE in 1 CARTON (0003-2328-22) / 40 mL in 1 VIAL, SINGLE-USE | 2011-03-25 | 0000-00-00 | No | No | Current |