NebuPent
- Product NDC
- 63323-877
- 11-digit product format
- 633230877
- Labeler code
- 63323
- Product ID
- 63323-877_d673c124-d95f-4751-a11a-a26de8740b3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PENTAMIDINE ISETHIONATE
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA019887
- Marketing category
- NDA
- Marketing start
- 2011-02-15
- Substance
- PENTAMIDINE ISETHIONATE
- Active strength
- 300 mg/6mL
- Pharmacologic classes
- Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NebuPent
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENTAMIDINE ISETHIONATE | 300 mg/6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V2P3K60DA2 |
| Rxcui | 861597, 861599 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-877-15 | NebuPent | 6 mL in 1 VIAL, SINGLE-DOSE | INHALANT | 6 | | 4 |
| 63323-877-15 | NebuPent | 1 in 1 CARTON | INHALANT | 1 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-877 | NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241020_e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb.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 |
|---|
| 63323-877-15 | 63323087715 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE | 2011-02-15 | 0000-00-00 | No | No | Current |