Amphotericin B
- Product NDC
- 62756-954
- 11-digit product format
- 627560954
- Labeler code
- 62756
- Product ID
- 62756-954_4acdbb90-5e56-4ab9-8a37-5dbeabc9c669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphotericin B
- Dosage form
- INJECTABLE, LIPOSOMAL
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA212514
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amphotericin B
- Listing expiration
- 2027-12-31
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 |
|---|
| 62756-954-01 | Amphotericin B | 1 in 1 CARTON | INJECTABLE, LIPOSOMAL | 1 | | 3 |
| 62756-954-01 | Amphotericin B | 1 in 1 VIAL, SINGLE-DOSE | INJECTABLE, LIPOSOMAL | 1 | | 3 |
| 62756-954-02 | Amphotericin B | 10 in 1 CARTON | INJECTABLE, LIPOSOMAL | 10 | | 3 |
| 62756-954-02 | Amphotericin B | 1 in 1 CARTON | INJECTABLE, LIPOSOMAL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-954 | AMPHOTERICIN B INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 2 | Current NDC, 4 package rows | 20250122_02aadef1-390b-4270-b56d-33452eb89dde.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62756-954-01 | 62756095401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE | | 2024-12-01 | No | No | Historical |
| 62756-954-02 | 62756095402 | 10 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE | 10 carton | 2024-12-01 | No | No | Historical |