Pentam 300
- Product NDC
- 63323-113
- 11-digit product format
- 633230113
- Labeler code
- 63323
- Product ID
- 63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PENTAMIDINE ISETHIONATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA019264
- Marketing category
- NDA
- Marketing start
- 2001-01-16
- 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
- Pentam 300
- 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, 861604 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-113-01 | Pentam 300 | 3 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 3 | | 3 |
| 63323-113-10 | Pentam 300 | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PENTAMIDINE ISETHIONATE | ACTIVE INGREDIENT | V2P3K60DA2 | PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| PENTAMIDINE | ACTIVE MOIETY | 673LC5J4LQ | PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-113 | PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220919_cc2b635e-4840-4dc3-a177-5484371680e8.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 |
|---|
| 63323-113-01 | 63323011301 | 3 mL in 1 VIAL | 3 ml | | | | | Historical |
| 63323-113-10 | 63323011310 | 10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01) | 10 vial | 2001-01-16 | 0000-00-00 | No | No | Current |