CARBOPLATIN
- Product NDC
- 54288-167
- 11-digit product format
- 542880167
- Labeler code
- 54288
- Product ID
- 54288-167_c0a7463c-d90f-4060-a54e-6a4888e8af0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carboplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BPI Labs LLC
- Application
- ANDA207324
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- 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 |
|---|
| 54288-167-01 | CARBOPLATIN | 60 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 60 | | 5 |
| 54288-167-01 | CARBOPLATIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54288-167 | CARBOPLATIN INJECTION, SOLUTION [BPI LABS LLC] | 4 | Current NDC, 2 package rows | 20250213_5484d2f0-0cc2-4bba-8f26-c7f6539a9606.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 54288-167-01 | 54288016701 | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-167-01) / 60 mL in 1 VIAL, MULTI-DOSE | 2023-07-31 | No | No | Current |