Oxaliplatin
- Product NDC
- 68083-177
- 11-digit product format
- 680830177
- Labeler code
- 68083
- Product ID
- 68083-177_4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207325
- Marketing category
- ANDA
- Marketing start
- 2017-11-06
- 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, 1797528 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-177-01 | Oxaliplatin | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 20 | | 10 |
| 68083-177-01 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-177 | OXALIPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 2 package rows | 20230826_a6f89dc3-a594-4b5b-8728-272e20c1ecb5.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 |
|---|
| 68083-177-01 | 68083017701 | 1 VIAL, SINGLE-USE in 1 CARTON (68083-177-01) / 20 mL in 1 VIAL, SINGLE-USE | 2017-11-06 | 0000-00-00 | No | No | Current |