Nipent
- Product NDC
- 0409-0801
- 11-digit product format
- 004090801
- Labeler code
- 0409
- Product ID
- 0409-0801_e2a13722-66e8-48df-bf6a-65eca64068e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PENTOSTATIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- NDA020122
- Marketing category
- NDA
- Marketing start
- 2007-08-15
- Substance
- PENTOSTATIN
- Active strength
- 2 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
- Nipent
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENTOSTATIN | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 395575MZO7 |
| Rxcui | 105607, 240573 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-0801-01 | Nipent | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 26 |
| 0409-0801-01 | Nipent | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PENTOSTATIN | ACTIVE INGREDIENT | 395575MZO7 | NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 13 | |
| PENTOSTATIN | ACTIVE MOIETY | 395575MZO7 | NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 13 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 13 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-0801 | NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 25 | Current NDC, Legacy NDC, 2 package rows | 20240927_674e0e6d-46ed-4868-9196-04019d667716.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 |
|---|
| 0409-0801-01 | 00409080101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2007-08-15 | 0000-00-00 | No | No | Current |