CLOFARABINE
- Product NDC
- 49315-003
- 11-digit product format
- 493150003
- Labeler code
- 49315
- Product ID
- 49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clofarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA204029
- Marketing category
- ANDA
- Marketing start
- 2017-05-10
- Substance
- CLOFARABINE
- Active strength
- 1 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
- CLOFARABINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOFARABINE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 762RDY0Y2H |
| Rxcui | 486419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49315-003-06 | CLOFARABINE | 20 mL in 1 VIAL, SINGLE-USE | INJECTION | 20 | | 2 |
| 49315-003-06 | CLOFARABINE | 1 in 1 CARTON | INJECTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49315-003 | CLOFARABINE INJECTION [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221019_4d8d8e81-01ba-4493-b458-7f6375c5bbae.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 |
|---|
| 49315-003-06 | 49315000306 | 1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE | 2017-05-10 | 0000-00-00 | No | No | Current |