ABELCET
- Product NDC
- 57665-101
- 11-digit product format
- 576650101
- Labeler code
- 57665
- Product ID
- 57665-101_ef1a50cb-a1a1-2602-e053-2a95a90a0e4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Leadiant Biosciences, Inc.
- Application
- NDA050724
- Marketing category
- NDA
- Marketing start
- 2010-10-18
- Marketing end
- 0000-00-00
- Substance
- AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-
- Active strength
- 5 mg/mL; mg/mL; mg/mL
- Pharmacologic classes
- Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMPHOTERICIN B | ACTIVE INGREDIENT | 7XU7A7DROE | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- | ACTIVE INGREDIENT | U86ZGC74V5 | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- | ACTIVE INGREDIENT | BI71WT9P3R | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| AMPHOTERICIN B | ACTIVE MOIETY | 7XU7A7DROE | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- | ACTIVE MOIETY | U86ZGC74V5 | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- | ACTIVE MOIETY | BI71WT9P3R | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57665-101 | ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [LEADIANT BIOSCIENCES, INC.] | 15 | Legacy NDC | 20231122_5587db37-f21a-4a39-a319-e1077032ced9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57665-101-41 | 57665010141 | 1 VIAL in 1 CARTON (57665-101-41) > 20 mL in 1 VIAL | 1 vial | 2010-10-18 | 0000-00-00 | No | No | Current |