OXALIPLATIN
- Product NDC
- 0955-1731
- 11-digit product format
- 009551731
- Labeler code
- 0955
- Product ID
- 0955-1731_0bef8406-8dab-0ad0-e063-6394a90a60d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxaliplatin
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Winthrop U.S, a business of sanofi-aventis U.S. LLC
- Application
- NDA021759
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-09-01
- 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 |
|---|
| 0955-1731-10 | OXALIPLATIN | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 10 |
| 0955-1731-10 | OXALIPLATIN | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION, CONCENTRATE | 10 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0955-1731 | OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231208_70269278-fe61-4800-a064-32cb6845cc28.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 |
|---|
| 0955-1731-10 | 00955173110 | 1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 mL in 1 VIAL, GLASS | 2015-09-01 | 0000-00-00 | No | No | Current |