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 |
|---|---|
| NIVOLUMAB | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31YO63LBSN | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1657190 | Internal RxNorm lookup |
| 1657192 | Internal RxNorm lookup |
| 1657195 | Internal RxNorm lookup |
| 1657196 | Internal RxNorm lookup |
| 1991412 | Internal RxNorm lookup |
| 1991413 | Internal RxNorm lookup |
| 2569080 | Internal RxNorm lookup |
| 2569081 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f570b9c4-6846-4de2-abfa-4d0a4ae4e394 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 64196b0b-840e-435b-8afa-0b0e9d9cea99 | Product name | 1 | 20251024 |
| cc8aeb65-d09e-4803-a7f6-91602fc46900 | Product name | 1 | 20230103 |
| d9ed9875-2de0-480e-b03d-305aab8310a6 | Product name | 2 | 20160211 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0003-3772-11 | ML - Milliliter | 0003-3772 | 3a2c87a4-f133-4782-a1fe-59b0bd58e725 | 1 | 2015-01-05 |
DailyMed Dashboard NDC Coverage#
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125554 | Opdivo | nivolumab | 351(a) | Rx | 2026-08-01 |
DailyMed RxNorm Mappings#
Packages#
| 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 |