Cyclophosphamide
- Product NDC
- 65219-131
- 11-digit product format
- 652190131
- Labeler code
- 65219
- Product ID
- 65219-131_fadfc813-11a5-415a-9d70-06c579e7619c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclophosphamide
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS; ORAL
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA204555
- Marketing category
- ANDA
- Marketing start
- 2023-11-17
- Substance
- CYCLOPHOSPHAMIDE
- Active strength
- 1 g/50mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclophosphamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOPHOSPHAMIDE | 1 g/50mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8N3DW7272P |
| Rxcui | 1734917, 1734919, 1734921 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-131-20 | Cyclophosphamide | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 50 | | 2 |
| 65219-131-20 | Cyclophosphamide | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-131 | CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, 2 package rows | 20241022_31986d36-a1bf-4903-93a4-ce7386241ba1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-131-20 | 65219013120 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-131-20) / 50 mL in 1 VIAL, SINGLE-DOSE | 2023-11-17 | No | No | Current |