Oxaliplatin
- Product NDC
- 68083-171
- 11-digit product format
- 680830171
- Labeler code
- 68083
- Product ID
- 68083-171_0d039035-85d1-40d4-8ee6-540026ab7a5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207385
- Marketing category
- ANDA
- Marketing start
- 2017-05-29
- Substance
- OXALIPLATIN
- Active strength
- 100 mg/20mL
- 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 | 100 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04ZR38536J |
| Rxcui | 1736784, 1736786 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-171-01 | Oxaliplatin | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-171 | OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 1 package rows | 20170529_d6178bc6-9dae-413f-8f47-de75d576c5b8.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 |
|---|
| 68083-171-01 | 68083017101 | 20 mL in 1 VIAL (68083-171-01) | 20 ml | 2017-05-29 | 0000-00-00 | No | No | Current |