Oxaliplatin
- Product NDC
- 67184-0510
- 11-digit product format
- 671840510
- Labeler code
- 67184
- Product ID
- 67184-0510_e78605b3-b28b-4634-9a58-d4bda67832ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA204368
- Marketing category
- ANDA
- Marketing start
- 2016-06-07
- Substance
- OXALIPLATIN
- Active strength
- 200 mg/40mL
- 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 | 200 mg/40mL |
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 |
|---|
| 67184-0510-1 | Oxaliplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 67184-0510-1 | Oxaliplatin | 40 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 40 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0510 | OXALIPLATIN INJECTION, SOLUTION OXALIPLATIN INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241116_33d4f4b4-bb4e-46af-9e89-df20154436d0.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 |
|---|
| 67184-0510-1 | 67184051001 | 1 VIAL, SINGLE-USE in 1 CARTON (67184-0510-1) / 40 mL in 1 VIAL, SINGLE-USE | 2016-06-07 | 0000-00-00 | No | No | Current |