CYCLOPHOSPHAMIDE
- Product NDC
- 75907-191
- 11-digit product format
- 759070191
- Labeler code
- 75907
- Product ID
- 75907-191_81f6f0e0-48f4-4eb1-95e5-b1463e5f53f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclophosphamide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Labratories Inc.
- Application
- NDA212501
- Marketing category
- NDA
- Marketing start
- 2024-06-20
- Substance
- CYCLOPHOSPHAMIDE ANHYDROUS
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOPHOSPHAMIDE ANHYDROUS | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6UXW23996M |
| Rxcui | 2386859 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75907-191-02 | CYCLOPHOSPHAMIDE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 75907-191-02 | CYCLOPHOSPHAMIDE | 2.5 mL in 1 VIAL | INJECTION, SOLUTION | 2.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75907-191 | CYCLOPHOSPHAMIDE INJECTION, SOLUTION [DR. REDDY'S LABRATORIES INC.] | 2 | Current NDC, 2 package rows | 20241003_a5818647-d840-e9d7-c7b8-6541b485e44e.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 |
|---|
| 75907-191-02 | 75907019102 | 1 VIAL in 1 CARTON (75907-191-02) / 2.5 mL in 1 VIAL | 1 vial | 2024-06-20 | No | No | Current |