Oxaliplatin
- Product NDC
- 0781-9317
- 11-digit product format
- 007819317
- Labeler code
- 0781
- Product ID
- 0781-9317_ac83b4cd-5026-4dd5-b733-125d28ba3c95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA078817
- Marketing category
- ANDA
- Marketing start
- 2016-07-01
- Substance
- OXALIPLATIN
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxaliplatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXALIPLATIN | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04ZR38536J |
| Rxcui | 1736776, 1736781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-9317-80 | Oxaliplatin | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 20 | | 8 |
| 0781-9317-80 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-9317 | OXALIPLATIN INJECTION, SOLUTION [SANDOZ INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250130_86f6c19d-30d1-42e3-8d46-5e3f45776e85.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 |
|---|
| 0781-9317-80 | 00781931780 | 1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80) / 20 mL in 1 VIAL, SINGLE-USE | 2016-07-01 | 0000-00-00 | No | No | Current |