Amphotericin B
- Product NDC
- 39822-1055
- 11-digit product format
- 398221055
- Labeler code
- 39822
- Product ID
- 39822-1055_ff6c6de5-ba12-4176-817f-359761f6e4bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphotericin B
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA063206
- Marketing category
- ANDA
- Marketing start
- 1992-04-29
- Substance
- AMPHOTERICIN B
- Active strength
- 50 mg/10mL
- 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/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7XU7A7DROE |
| Rxcui | 239240 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-1055-5 | Amphotericin B | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMPHOTERICIN B | ACTIVE INGREDIENT | 7XU7A7DROE | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| AMPHOTERICIN B | ACTIVE MOIETY | 7XU7A7DROE | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| DEOXYCHOLIC ACID | INACTIVE INGREDIENT | 005990WHZZ | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-1055 | AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20220121_a0a54943-9ce4-4f3e-b681-a1a9144c16ce.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 |
|---|
| 39822-1055-5 | 39822105505 | 10 mL in 1 VIAL (39822-1055-5) | 10 ml | 1992-04-29 | 0000-00-00 | No | No | Current |