Clofarabine
- Product NDC
- 71288-128
- 11-digit product format
- 712880128
- Labeler code
- 71288
- Product ID
- 71288-128_06e3bdb0-c175-4e35-a15e-2779a54004ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clofarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213461
- Marketing category
- ANDA
- Marketing start
- 2020-10-23
- 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 |
|---|
| 71288-128-20 | Clofarabine | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 4 |
| 71288-128-20 | Clofarabine | 1 in 1 CARTON | INJECTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-128 | CLOFARABINE INJECTION [MEITHEAL PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221213_54436453-882e-406b-87a3-049d150101c6.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 |
|---|
| 71288-128-20 | 71288012820 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE | 2020-10-23 | 0000-00-00 | No | No | Current |