PARAPLATIN
- Product NDC
- 69448-005
- 11-digit product format
- 694480005
- Labeler code
- 69448
- Product ID
- 69448-005_e69a06ea-e917-25ea-e053-2995a90a6f6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carboplatin
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Accord BioPharma Inc.
- Application
- ANDA206775
- Marketing category
- ANDA
- Marketing start
- 2020-02-12
- Marketing end
- 0000-00-00
- Substance
- CARBOPLATIN
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69448-005 | PARAPLATIN (CARBOPLATIN) INJECTION [ACCORD BIOPHARMA INC.] | 4 | Legacy NDC | 20220820_f88e0483-09be-4f60-be8f-964c02e3ece0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69448-005-12 | 69448000512 | 1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-12) > 60 mL in 1 VIAL, MULTI-DOSE | 2020-02-12 | 0000-00-00 | No | No | Current |
| 69448-005-31 | 69448000531 | 1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-31) > 5 mL in 1 VIAL, MULTI-DOSE | 2020-02-12 | 0000-00-00 | No | No | Current |
| 69448-005-33 | 69448000533 | 1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-33) > 15 mL in 1 VIAL, MULTI-DOSE | 2020-02-12 | 0000-00-00 | No | No | Current |
| 69448-005-34 | 69448000534 | 1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-34) > 45 mL in 1 VIAL, MULTI-DOSE | 2020-02-12 | 0000-00-00 | No | No | Current |
| 69448-005-38 | 69448000538 | 1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-38) > 100 mL in 1 VIAL, MULTI-DOSE | 2020-08-17 | 0000-00-00 | No | No | Current |