Oxaliplatin
- Product NDC
- 55150-331
- 11-digit product format
- 551500331
- Labeler code
- 55150
- Product ID
- 55150-331_faf81c5b-2d7e-4e6f-825b-f8a8399c0066
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA205529
- Marketing category
- ANDA
- Marketing start
- 2017-09-21
- 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 |
|---|
| 55150-331-01 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 55150-331-01 | Oxaliplatin | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-331 | OXALIPLATIN INJECTION, SOLUTION [EUGIA US LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240710_1bb4febd-0ed4-48c9-ba2a-e22183a2143f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-331-01 | 55150033101 | 1 VIAL in 1 CARTON (55150-331-01) / 10 mL in 1 VIAL | 1 vial | 2017-09-21 | 0000-00-00 | No | No | Current |