pentamidine isethionate
- Product NDC
- 23155-748
- 11-digit product format
- 231550748
- Labeler code
- 23155
- Product ID
- 23155-748_77269af7-78f2-4f7d-bfe9-bdcd2bedaa86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pentamidine isethionate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA213806
- Marketing category
- ANDA
- Marketing start
- 2021-01-08
- Substance
- PENTAMIDINE ISETHIONATE
- Active strength
- 300 mg/300mg
- 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/300mg |
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 |
|---|
| 23155-748-31 | pentamidine isethionate | 300 mg in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 300 | | 7 |
| 23155-748-41 | pentamidine isethionate | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-748 | PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20231102_5c14fbf2-e21f-44b3-b35c-06919d40d7e0.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 |
|---|
| 23155-748-31 | 23155074831 | 300 mg in 1 VIAL, SINGLE-DOSE | 300 mg | | | | | Historical |
| 23155-748-41 | 23155074841 | 10 VIAL, SINGLE-DOSE in 1 CARTON (23155-748-41) / 300 mg in 1 VIAL, SINGLE-DOSE (23155-748-31) | | 2021-01-08 | 0000-00-00 | No | No | Current |