Amphotericin B
- Product NDC
- 55150-365
- 11-digit product format
- 551500365
- Labeler code
- 55150
- Product ID
- 55150-365_9f45e5d9-6acd-491e-a80c-f07ecc6ac109
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphotericin B
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA214010
- Marketing category
- ANDA
- Marketing start
- 2022-11-17
- 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
- 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 |
|---|
| 55150-365-01 | Amphotericin B | 12.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 12.5 | | 2 |
| 55150-365-01 | Amphotericin B | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-365 | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221123_6f24975c-5191-4fc2-a8da-e57358f8e154.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-365-01 | 55150036501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | 0000-00-00 | No | No | Current |