Fludarabine phosphate
- Product NDC
- 45963-609
- 11-digit product format
- 459630609
- Labeler code
- 45963
- Product ID
- 45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludarabine phosphate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078610
- Marketing category
- ANDA
- Marketing start
- 2015-01-05
- Substance
- FLUDARABINE PHOSPHATE
- Active strength
- 50 mg/2mL
- 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 phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUDARABINE PHOSPHATE | 50 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1X9VK9O1SC |
| Rxcui | 1740864 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-609-55 | Fludarabine phosphate | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
| 45963-609-55 | Fludarabine phosphate | 2 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 2 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUDARABINE PHOSPHATE | ACTIVE INGREDIENT | 1X9VK9O1SC | FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] | 8 | |
| FLUDARABINE | ACTIVE MOIETY | P2K93U8740 | FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] | 8 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-609 | FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240403_3adca34b-4f65-4e21-8058-3c01fc7fc9bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-609-55 | 45963060955 | 1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS | 2015-01-05 | 0000-00-00 | No | No | Current |