OPDIVO
- Product NDC
- 0003-3772
- 11-digit product format
- 000033772
- Labeler code
- 0003
- Product ID
- 0003-3772_645d02cf-536a-4ceb-b812-660735b38e92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nivolumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- BLA125554
- Marketing category
- BLA
- Marketing start
- 2014-12-22
- Substance
- NIVOLUMAB
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OPDIVO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIVOLUMAB | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31YO63LBSN |
| Rxcui | 1657190, 1657192, 1657195, 1657196, 1991412, 1991413, 2569080, 2569081 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-3772-11 | OPDIVO | 1 in 1 CARTON | INJECTION | 1 | | 67 |
| 0003-3772-11 | OPDIVO | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 4 | | 67 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-3772 | OPDIVO (NIVOLUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] | 61 | Current NDC, Legacy NDC, 2 package rows | 20250426_f570b9c4-6846-4de2-abfa-4d0a4ae4e394.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 |
|---|
| 0003-3772-11 | 00003377211 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11) / 4 mL in 1 VIAL, SINGLE-DOSE | 2014-12-22 | 0000-00-00 | No | No | Current |