Amphotericin B liposome
- Product NDC
- 67457-926
- 11-digit product format
- 674570926
- Labeler code
- 67457
- Product ID
- 67457-926_a96a734f-d1c4-4d42-93c2-7c336da7f7b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphotericin B liposome
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA212967
- Marketing category
- ANDA
- Marketing start
- 2025-08-06
- Substance
- AMPHOTERICIN B
- Active strength
- 50 mg/12.5mL
- 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 liposome
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMPHOTERICIN B | 50 mg/12.5mL |
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 |
|---|
| 67457-926-50 | Amphotericin B liposome | 12.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 12.5 | | 1 |
| 67457-926-50 | Amphotericin B liposome | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 67457-926-99 | Amphotericin B liposome | 10 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
| 67457-926-99 | Amphotericin B liposome | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67457-926-50 | 67457092650 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE | 2025-08-06 | No | No | Historical |
| 67457-926-99 | 67457092699 | 10 in 1 BOX | | | | Historical |