CISPLATIN
- Product NDC
- 68083-163
- 11-digit product format
- 680830163
- Labeler code
- 68083
- Product ID
- 68083-163_89007399-3c34-40d2-8068-a0b8e09cbef8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cisplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207323
- Marketing category
- ANDA
- Marketing start
- 2017-04-03
- 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 |
|---|
| 68083-163-01 | CISPLATIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
| 68083-163-01 | CISPLATIN | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-163 | CISPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20231018_a32820f7-9ff6-4c13-a96a-4483a943fe82.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 |
|---|
| 68083-163-01 | 68083016301 | 1 VIAL in 1 CARTON (68083-163-01) / 100 mL in 1 VIAL | 1 vial | 2017-04-03 | 0000-00-00 | No | No | Current |