Colistimethate
- Product NDC
- 70594-023
- 11-digit product format
- 705940023
- Labeler code
- 70594
- Product ID
- 70594-023_89aaab5f-68ab-4848-b9c6-a4e1051aaf4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colistimethate sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA205356
- Marketing category
- ANDA
- Marketing start
- 2022-02-20
- Substance
- COLISTIMETHATE SODIUM
- Active strength
- 150 mg/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
- Colistimethate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLISTIMETHATE SODIUM | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XW0E5YS77G |
| Rxcui | 1117522 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70594-023-01 | Colistimethate | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 5 |
| 70594-023-01 | Colistimethate | 1 in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 5 |
| 70594-023-04 | Colistimethate | 12 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 12 | | 5 |
| 70594-023-04 | Colistimethate | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 5 |
| 70594-023-09 | Colistimethate | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 3 |
| 70594-023-09 | Colistimethate | 1 in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-023 | COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240913_8ec7dc90-825c-422e-9f4b-c8ace9d93af5.zip |
| 70594-023 | COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240831_13dc3525-1879-4bd8-a922-81bc1397d5af.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 |
|---|
| 70594-023-01 | 70594002301 | 1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | | 2018-10-01 | 0000-00-00 | No | No | Current |
| 70594-023-04 | 70594002304 | 12 VIAL, GLASS in 1 CARTON (70594-023-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | | 2018-10-01 | 0000-00-00 | No | No | Current |
| 70594-023-09 | 70594002309 | 1 VIAL in 1 CARTON (70594-023-09) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 1 vial | 2022-02-20 | 0000-00-00 | No | No | Current |