Cisplatin
- Product NDC
- 63323-103
- 11-digit product format
- 633230103
- Labeler code
- 63323
- Product ID
- 63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CISPLATIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA074735
- Marketing category
- ANDA
- Marketing start
- 2000-09-05
- Substance
- CISPLATIN
- Active strength
- 1 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
- Cisplatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CISPLATIN | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q20Q21Q62J |
| Rxcui | 309311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-103-51 | Cisplatin | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 7 |
| 63323-103-51 | Cisplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 63323-103-64 | Cisplatin | 200 mL in 1 VIAL | INJECTION, SOLUTION | 200 | | 7 |
| 63323-103-64 | Cisplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 63323-103-65 | Cisplatin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 63323-103-65 | Cisplatin | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CISPLATIN | ACTIVE INGREDIENT | Q20Q21Q62J | CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| CISPLATIN | ACTIVE MOIETY | Q20Q21Q62J | CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-103 | CISPLATIN (CISPLATIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241013_de6302d5-85f0-4116-a709-57826c2c84fe.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 |
|---|
| 63323-103-51 | 63323010351 | 1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL | 1 vial | 2000-09-05 | 0000-00-00 | No | No | Current |
| 63323-103-64 | 63323010364 | 1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL | 1 vial | 2000-09-05 | 0000-00-00 | No | No | Current |
| 63323-103-65 | 63323010365 | 1 VIAL in 1 CARTON (63323-103-65) / 100 mL in 1 VIAL | 1 vial | 2000-09-05 | 0000-00-00 | No | No | Current |