AmBisome
- Product NDC
- 0469-3051
- 11-digit product format
- 004693051
- Labeler code
- 0469
- Product ID
- 0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amphotericin B
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Astellas Pharma US, Inc.
- Application
- NDA050740
- Marketing category
- NDA
- Marketing start
- 1997-08-11
- 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
- AmBisome
- 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, 967388 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0469-3051-30 | AmBisome | 12.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 12.5 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMPHOTERICIN B | ACTIVE INGREDIENT | 7XU7A7DROE | AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 4 | |
| AMPHOTERICIN B | ACTIVE MOIETY | 7XU7A7DROE | AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0469-3051 | AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20241116_f7be6506-4d20-401e-a0ff-02ad7c33158a.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 |
|---|
| 0469-3051-30 | 00469305130 | 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30) | 12.5 ml | 1997-08-11 | 0000-00-00 | No | No | Current |