Cyclophosphamide
- Product NDC
- 68001-696
- 11-digit product format
- 680010696
- Labeler code
- 68001
- Product ID
- 68001-696_4cd3801f-1a1a-33fd-e063-6294a90aa2b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclophosphamide
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS; ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA218644
- Marketing category
- ANDA
- Marketing start
- 2026-03-15
- Substance
- CYCLOPHOSPHAMIDE
- Active strength
- 2 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclophosphamide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CYCLOPHOSPHAMIDE | 2 g/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 8N3DW7272P |
| Rxcui | 1734917, 1734919, 1734921 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0db1850b-2dc3-47a1-8b35-fab6e1685124 | Product name | 3 | 20250814 |
| 0b38b013-6fe7-0a7a-ece2-0a10ca467a97 | Product name | 4 | 20250801 |
| f22fb018-dc36-4ffa-a765-94776b98899b | Product name | 1 | 20250620 |
| e71baeca-a07a-452b-ba2b-50be55aedc79 | Product name | 2 | 20250617 |
| 913f6711-71c9-4a3d-a6d5-98cbd101b5d8 | Product name | 1 | 20231023 |
| cd3d0a71-dbf2-4640-91f7-c99c45edfbb6 | Product name | 1 | 20231023 |
| fbc3d08d-10bd-4e59-b59d-d530aede5bad | Product name | 1 | 20220308 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-696-32 | Cyclophosphamide | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 100 | 1 | |
| 68001-696-32 | Cyclophosphamide | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1734919 | cycloPHOSphamide 1 GM Injection | PSN | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734921 | cycloPHOSphamide 2 GM Injection | PSN | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734917 | cycloPHOSphamide 500 MG Injection | PSN | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734919 | cyclophosphamide 1000 MG Injection | SCD | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734921 | cyclophosphamide 2000 MG Injection | SCD | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734917 | cyclophosphamide 500 MG Injection | SCD | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734919 | cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG Injection | SY | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734921 | cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG Injection | SY | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734917 | cyclophosphamide (as cyclophosphamide monohydrate) 500 MG Injection | SY | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734919 | cyclophosphamide 1 GM Injection | SY | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
| 1734921 | cyclophosphamide 2 GM Injection | SY | 1d3396d8-4c03-4a28-890a-d87c6c53a74e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68001-696-32 | 68001069632 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-696-32) / 100 mL in 1 VIAL, SINGLE-DOSE | 2026-03-15 | No | No | Historical |