Fludarabine Phosphate
- Product NDC
- 0527-1242
- 11-digit product format
- 005271242
- Labeler code
- 0527
- Product ID
- 0527-1242_1b10ebb9-8a76-41c8-bf18-166e54471b0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludarabine Phosphate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Lannett Company, Inc.
- Application
- ANDA090724
- Marketing category
- ANDA
- Marketing start
- 2019-12-31
- 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 Phosphate
- 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 |
|---|
| 0527-1242-02 | Fludarabine Phosphate | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 0527-1242-02 | Fludarabine Phosphate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1242 | FLUDARABINE PHOSPHATE INJECTION [LANNETT COMPANY, INC.] | 1 | Current NDC, 2 package rows | 20230404_0170c0f4-d502-4f8f-bdbf-6439f3ed33fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0527-1242-02 | 00527124202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2019-12-31 | No | No | Current |