Cyclophosphamide
- Product NDC
- 83831-117
- 11-digit product format
- 838310117
- Labeler code
- 83831
- Product ID
- 83831-117_5fc45658-c2d9-41de-821f-ff6f40a469dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclophosphamide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA210852
- Marketing category
- NDA
- Marketing start
- 2024-08-01
- Substance
- CYCLOPHOSPHAMIDE
- Active strength
- 1 g/2mL
- 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/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8N3DW7272P |
| Rxcui | 2644738, 2644751, 2644824 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-117-02 | Cyclophosphamide | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 83831-117-02 | Cyclophosphamide | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83831-117 | CYCLOPHOSPHAMIDE INJECTION [AVYXA PHARMA, LLC] | 3 | Current NDC, 2 package rows | 20240802_6f593585-e0dd-48bc-bd2b-c6c787e0b98c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83831-117-02 | 83831011702 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-117-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2024-08-01 | No | No | Current |