Polymyxin B
- Product NDC
- 63323-367
- 11-digit product format
- 633230367
- Labeler code
- 63323
- Product ID
- 63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA202766
- Marketing category
- ANDA
- Marketing start
- 2015-09-09
- 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 |
|---|
| 63323-367-41 | Polymyxin B | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 63323-367-44 | Polymyxin B | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-367 | POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221203_72dd6de6-31d6-4a8f-881b-91af91ed9314.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 |
|---|
| 63323-367-11 | 63323036711 | 10 VIAL in 1 CARTON (63323-367-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01) | 10 vial | 2015-09-09 | 0000-00-00 | No | No | Current |
| 63323-367-41 | 63323036741 | 1 in 1 VIAL, GLASS | | | | | | Historical |
| 63323-367-44 | 63323036744 | 10 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41) | | 2015-09-09 | 0000-00-00 | No | No | Current |