Polymyxin B
- Product NDC
- 25021-196
- 11-digit product format
- 250210196
- Labeler code
- 25021
- Product ID
- 25021-196_1d99f0e9-015c-4be1-b110-bdd156846dd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA207322
- Marketing category
- ANDA
- Marketing start
- 2025-10-01
- 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 |
|---|
| 25021-196-10 | Polymyxin B | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
| 25021-196-10 | Polymyxin B | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-196-10 | 25021019610 | 10 VIAL in 1 CARTON (25021-196-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 10 vial | 2025-10-01 | No | No | Historical |