Oxaliplatin
- Product NDC
- 60505-6132
- 11-digit product format
- 605056132
- Labeler code
- 60505
- Product ID
- 60505-6132_3960461c-958a-43c1-a685-522039b021df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp.
- Application
- ANDA204368
- Marketing category
- ANDA
- Marketing start
- 2017-01-04
- 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 |
|---|
| 60505-6132-6 | Oxaliplatin | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 17 |
| 60505-6132-6 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 17 |
| 60505-6132-7 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 17 |
| 60505-6132-7 | Oxaliplatin | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 17 |
| 60505-6132-8 | Oxaliplatin | 40 mL in 1 VIAL | INJECTION, SOLUTION | 40 | | 17 |
| 60505-6132-8 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6132 | OXALIPLATIN INJECTION, SOLUTION [APOTEX CORP.] | 16 | Current NDC, Legacy NDC, 6 package rows | 20230217_ee5a5a1d-63f6-4d5a-901b-65be45ec6610.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 |
|---|
| 60505-6132-6 | 60505613206 | 1 VIAL in 1 CARTON (60505-6132-6) / 10 mL in 1 VIAL | 1 vial | 2017-01-04 | 0000-00-00 | No | No | Current |
| 60505-6132-7 | 60505613207 | 1 VIAL in 1 CARTON (60505-6132-7) / 20 mL in 1 VIAL | 1 vial | 2017-01-04 | 0000-00-00 | No | No | Current |
| 60505-6132-8 | 60505613208 | 1 VIAL in 1 CARTON (60505-6132-8) / 40 mL in 1 VIAL | 1 vial | 2020-11-05 | 0000-00-00 | No | No | Current |