POLYMYXIN B
- Product NDC
- 63323-321
- 11-digit product format
- 633230321
- Labeler code
- 63323
- Product ID
- 63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- POLYMYXIN B SULFATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065372
- Marketing category
- ANDA
- Marketing start
- 2009-11-17
- 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 |
|---|
| 63323-321-01 | POLYMYXIN B | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 63323-321-10 | POLYMYXIN B | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
| 63323-321-02 | POLYMYXIN B | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 63323-321-12 | POLYMYXIN B | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-321 | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210319_fbc12c18-567b-41bc-89d0-efd29616615c.zip |
| 63323-321 | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210610_704a41f5-b109-4c16-8d3e-1495c9917952.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 |
|---|
| 63323-321-01 | 63323032101 | 1 in 1 VIAL | | | | | | Historical |
| 63323-321-02 | 63323032102 | 1 in 1 VIAL | | | | | | Historical |
| 63323-321-10 | 63323032110 | 10 VIAL in 1 TRAY (63323-321-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01) | 10 vial | 2009-11-17 | 0000-00-00 | No | No | Current |
| 63323-321-12 | 63323032112 | 10 VIAL in 1 TRAY (63323-321-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-02) | 10 vial | 2009-11-17 | 0000-00-00 | No | No | Current |