Cyclophosphamide
- Product NDC
- 0338-9779
- 11-digit product format
- 003389779
- Labeler code
- 0338
- Product ID
- 0338-9779_4f8ec65c-284b-4a7e-86d6-d3ced9cef625
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclophosphamide injection, solution
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- Application
- NDA217651
- Marketing category
- NDA
- Marketing start
- 2024-08-01
- Substance
- CYCLOPHOSPHAMIDE
- Active strength
- 200 mg/mL
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOPHOSPHAMIDE | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8N3DW7272P |
| Rxcui | 2386859 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-9779-01 | Cyclophosphamide | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 0338-9779-01 | Cyclophosphamide | 5 mL in 1 VIAL | INJECTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-9779 | CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE INJECTION, SOLUTION) INJECTION [BAXTER HEALTHCARE COMPANY] | 2 | Current NDC, 2 package rows | 20250416_34dbffee-80e0-49c3-90e8-95713a0b7fbe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0338-9779-01 | 00338977901 | 1 VIAL in 1 CARTON (0338-9779-01) / 5 mL in 1 VIAL | 1 vial | 2024-08-01 | No | No | Current |