Colistimethate
- Product NDC
- 63323-393
- 11-digit product format
- 633230393
- Labeler code
- 63323
- Product ID
- 63323-393_4637a207-5042-4af6-a7a7-e63cd472b0d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLISTIMETHATE SODIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065364
- Marketing category
- ANDA
- Marketing start
- 2009-12-04
- Substance
- COLISTIMETHATE SODIUM
- Active strength
- 150 mg/2mL
- 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/2mL |
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 |
|---|
| 63323-393-06 | Colistimethate | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 63323-393-06 | Colistimethate | 2 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 2 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COLISTIMETHATE SODIUM | ACTIVE INGREDIENT | XW0E5YS77G | COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| COLISTIMETHATE | ACTIVE MOIETY | DL2R53P963 | COLISTIMETHATE (COLISTIMETHATE SODIUM) 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 |
|---|
| 63323-393 | COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20200430_ab241809-0d2f-44ba-829c-26be67ee623f.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 |
|---|
| 63323-393-06 | 63323039306 | 1 VIAL in 1 BOX (63323-393-06) / 2 mL in 1 VIAL | 1 vial | 2009-12-04 | 0000-00-00 | No | No | Current |