Oxaliplatin
- Product NDC
- 67184-0502
- 11-digit product format
- 671840502
- Labeler code
- 67184
- Product ID
- 67184-0502_f9f54aa0-22e3-4958-b368-d89d716ac2fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA204616
- Marketing category
- ANDA
- Marketing start
- 2016-05-11
- 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 |
|---|
| 67184-0502-1 | Oxaliplatin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 3 |
| 67184-0502-1 | Oxaliplatin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0502 | OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211020_e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64.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 |
|---|
| 67184-0502-1 | 67184050201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67184-0502-1) / 20 mL in 1 VIAL, SINGLE-DOSE | 2016-05-11 | 0000-00-00 | No | No | Current |