Oxaliplatin
- Product NDC
- 72603-320
- 11-digit product format
- 726030320
- Labeler code
- 72603
- Product ID
- 72603-320_9ebe158f-dd21-4bb8-ac13-d18162773cef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Northstar Rx LLC
- Application
- ANDA217348
- Marketing category
- ANDA
- Marketing start
- 2024-01-11
- 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 |
|---|
| 72603-320-01 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 72603-320-01 | Oxaliplatin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-320 | OXALIPLATIN INJECTION, SOLUTION [NORTHSTAR RX LLC] | 2 | Current NDC, 2 package rows | 20241019_7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-320-01 | 72603032001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-320-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2024-01-11 | No | No | Current |