Amphotericin B
- Product NDC
- 23155-594
- 11-digit product format
- 231550594
- Labeler code
- 23155
- Product ID
- 23155-594_9de2927d-27ac-4890-ad71-a737dd4d3881
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphotericin B
- Dosage form
- INJECTABLE, LIPOSOMAL
- Route
- INTRAVENOUS
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA215354
- Marketing category
- ANDA
- Marketing start
- 2025-06-20
- Substance
- AMPHOTERICIN B
- Active strength
- 50 mg/1
- Pharmacologic classes
- Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amphotericin B
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMPHOTERICIN B | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7XU7A7DROE |
| Rxcui | 967385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23155-594-31 | Amphotericin B | 1 in 1 VIAL, SINGLE-DOSE | INJECTABLE, LIPOSOMAL | 1 | | 4 |
| 23155-594-31 | Amphotericin B | 1 in 1 CARTON | INJECTABLE, LIPOSOMAL | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-594-31 | 23155059431 | 1 VIAL, SINGLE-DOSE in 1 CARTON (23155-594-31) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE | 2025-06-20 | No | No | Current |