Fludarabine
- Product NDC
- 63323-192
- 11-digit product format
- 633230192
- Labeler code
- 63323
- Product ID
- 63323-192_fc26c9ee-50de-4eff-b264-1882edd65414
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUDARABINE PHOSPHATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA078393
- Marketing category
- ANDA
- Marketing start
- 2007-11-16
- Substance
- FLUDARABINE PHOSPHATE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fludarabine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUDARABINE PHOSPHATE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1X9VK9O1SC |
| Rxcui | 1740865 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-192-02 | Fludarabine | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 5 |
| 63323-192-02 | Fludarabine | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUDARABINE PHOSPHATE | ACTIVE INGREDIENT | 1X9VK9O1SC | FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 2 | |
| FLUDARABINE | ACTIVE MOIETY | P2K93U8740 | FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-192 | FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241019_cf5255cc-91fd-4132-973b-764dba142eae.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 |
|---|
| 63323-192-02 | 63323019202 | 1 VIAL in 1 BOX (63323-192-02) / 2 mL in 1 VIAL | 1 vial | 2007-11-16 | 0000-00-00 | No | No | Current |