Polymyxin B
- Product NDC
- 70594-049
- 11-digit product format
- 705940049
- Labeler code
- 70594
- Product ID
- 70594-049_fda91987-b6cd-4233-b09c-0f0300ad5df2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA202766
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- Substance
- POLYMYXIN B SULFATE
- Active strength
- 500000 [USP'U]/1
- Pharmacologic classes
- Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Polymyxin B
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYMYXIN B SULFATE | 500000 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19371312D4 |
| Rxcui | 204509 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70594-049-01 | Polymyxin B | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 12 |
| 70594-049-01 | Polymyxin B | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 12 |
| 70594-049-02 | Polymyxin B | 10 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 10 | | 12 |
| 70594-049-02 | Polymyxin B | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-049 | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250224_b56f18c0-ef5e-4ed9-a5af-f79f3cd189b6.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 |
|---|
| 70594-049-01 | 70594004901 | 1 VIAL, GLASS in 1 CARTON (70594-049-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | 2018-10-01 | 0000-00-00 | No | No | Current |
| 70594-049-02 | 70594004902 | 10 VIAL, GLASS in 1 CARTON (70594-049-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | 2018-10-01 | 0000-00-00 | No | No | Current |