PENTAMIDINE ISETHIONATE
- Product NDC
- 39822-3050
- 11-digit product format
- 398223050
- Labeler code
- 39822
- Product ID
- 39822-3050_0fcb7bdf-013e-a77c-e063-6394a90ad20f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PENTAMIDINE ISETHIONATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA206982
- Marketing category
- ANDA
- Marketing start
- 2023-04-04
- Substance
- PENTAMIDINE ISETHIONATE
- Active strength
- 300 mg/3mL
- 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
- PENTAMIDINE ISETHIONATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENTAMIDINE ISETHIONATE | 300 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V2P3K60DA2 |
| Rxcui | 861601 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-3050-2 | PENTAMIDINE ISETHIONATE | 3 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 3 | | 6 |
| 39822-3050-2 | PENTAMIDINE ISETHIONATE | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-3050 | PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240202_860c799c-5199-4f0c-b21b-9910273474d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 39822-3050-2 | 39822305002 | 10 VIAL in 1 CARTON (39822-3050-2) / 3 mL in 1 VIAL | 10 vial | 2023-04-04 | 0000-00-00 | No | No | Current |