Oxaliplatin
- Product NDC
- 0703-3986
- 11-digit product format
- 007033986
- Labeler code
- 0703
- Product ID
- 0703-3986_ef9edd2b-00c3-4faf-8083-354d0f363357
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxaliplatin
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- NDA022160
- Marketing category
- NDA
- Marketing start
- 2009-08-11
- Marketing end
- 0000-00-00
- Substance
- OXALIPLATIN
- Active strength
- 100 mg/20mL
- Pharmacologic classes
- Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXALIPLATIN | ACTIVE INGREDIENT | 04ZR38536J | OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 6 | |
| OXALIPLATIN | ACTIVE MOIETY | 04ZR38536J | OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0703-3986 | OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 14 | Legacy NDC | 20241103_9e51cc79-620c-48d7-b267-78e43c1ef6e4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0703-3986-01 | 00703398601 | 1 VIAL, SINGLE-USE in 1 CARTON (0703-3986-01) > 20 mL in 1 VIAL, SINGLE-USE | 2009-08-11 | 0000-00-00 | No | No | Current |