CARBOPLATIN
- Product NDC
- 68083-192
- 11-digit product format
- 680830192
- Labeler code
- 68083
- Product ID
- 68083-192_5af07c55-5bef-4da3-91fa-9b3d8d1253d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carboplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207324
- Marketing category
- ANDA
- Marketing start
- 2017-02-20
- Substance
- CARBOPLATIN
- Active strength
- 10 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
- CARBOPLATIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBOPLATIN | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BG3F62OND5 |
| Rxcui | 597195 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-192-01 | CARBOPLATIN | 45 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 45 | | 4 |
| 68083-192-01 | CARBOPLATIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-192 | CARBOPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240809_9eb057eb-29ce-40d2-9ac8-ed107f25f5ab.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 |
|---|
| 68083-192-01 | 68083019201 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-192-01) / 45 mL in 1 VIAL, MULTI-DOSE | 2017-02-20 | 0000-00-00 | No | No | Current |