oxaliplatin
- Product NDC
- 42677-337
- 11-digit product format
- 426770337
- Labeler code
- 42677
- Product ID
- 42677-337_4f6846af-385e-b624-e063-6394a90a28d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Shandong New Time Pharmaceutical Co., Ltd.
- Application
- ANDA219765
- Marketing category
- ANDA
- Marketing start
- 2026-01-15
- Substance
- OXALIPLATIN
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- oxaliplatin
- Listing expiration
- 2027-12-31
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 |
|---|
| 42677-337-01 | oxaliplatin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 2 |
| 42677-337-10 | oxaliplatin | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42677-337-01 | 42677033701 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | Historical |
| 42677-337-10 | 42677033710 | 10 VIAL, SINGLE-DOSE in 1 CARTON (42677-337-10) / 20 mL in 1 VIAL, SINGLE-DOSE (42677-337-01) | | 2026-01-15 | No | No | Current |