Oxaliplatin
- Product NDC
- 31722-357
- 11-digit product format
- 317220357
- Labeler code
- 31722
- Product ID
- 31722-357_3fee20f4-5fee-8b4e-e063-6294a90a1a0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA217925
- Marketing category
- ANDA
- Marketing start
- 2025-01-27
- Substance
- OXALIPLATIN
- Active strength
- 50 mg/10mL
- 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 | 50 mg/10mL |
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 |
|---|
| 31722-357-10 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 1 |
| 31722-357-10 | Oxaliplatin | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-357-10 | 31722035710 | 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-357-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-01-27 | No | No | Current |