Cyclophosphamide
- Product NDC
- 0054-0383
- 11-digit product format
- 000540383
- Labeler code
- 0054
- Product ID
- 0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclophosphamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA203856
- Marketing category
- NDA
- Marketing start
- 2013-09-16
- Substance
- CYCLOPHOSPHAMIDE
- Active strength
- 50 mg/1
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8N3DW7272P |
| Rxcui | 1437968, 1437969 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0383-13 | Cyclophosphamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 12 |
| 0054-0383-25 | Cyclophosphamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOPHOSPHAMIDE | ACTIVE INGREDIENT | 8N3DW7272P | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| CYCLOPHOSPHAMIDE ANHYDROUS | ACTIVE MOIETY | 6UXW23996M | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0383 | CYCLOPHOSPHAMIDE CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241122_8135b917-882f-4b4c-99b7-fa8ea54af4bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0383-13 | 00054038313 | 30 in 1 BOTTLE | | | | | | Historical |
| 0054-0383-25 | 00054038325 | 100 CAPSULE in 1 BOTTLE (0054-0383-25) | 100 capsule | 2013-09-16 | 0000-00-00 | No | No | Current |