CARBOPLATIN
- Product NDC
- 55150-335
- 11-digit product format
- 551500335
- Labeler code
- 55150
- Product ID
- 55150-335_5abfcb87-bb02-4384-9c9d-7d0e3e809311
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBOPLATIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA205487
- Marketing category
- ANDA
- Marketing start
- 2016-09-29
- Substance
- CARBOPLATIN
- Active strength
- 450 mg/45mL
- 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 | 450 mg/45mL |
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 |
|---|
| 55150-335-01 | CARBOPLATIN | 45 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 45 | | 4 |
| 55150-335-01 | CARBOPLATIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 55150-335-00 | CARBOPLATIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 55150-335-00 | CARBOPLATIN | 45 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 45 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-335 | CARBOPLATIN INJECTION, SOLUTION [EUGIA US LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250130_f5fe9a20-47a5-45b9-ab06-c6158d9b6aca.zip |
| 55150-335 | CARBOPLATIN INJECTION, SOLUTION [EUGIA US LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20250202_5abfcb87-bb02-4384-9c9d-7d0e3e809311.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 |
|---|
| 55150-335-00 | 55150033500 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-335-00) / 45 mL in 1 VIAL, MULTI-DOSE | 2016-09-29 | | No | No | Historical |
| 55150-335-01 | 55150033501 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-335-01) / 45 mL in 1 VIAL, MULTI-DOSE | 2016-09-29 | 0000-00-00 | No | No | Current |