Colistimethate
- Product NDC
- 39822-0615
- 11-digit product format
- 398220615
- Labeler code
- 39822
- Product ID
- 39822-0615_eedca302-5a83-6a5c-e053-2a95a90a7144
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colistimethate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA064216
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Marketing end
- 0000-00-00
- Substance
- COLISTIMETHATE SODIUM
- Active strength
- 150 mg/2mL
- Pharmacologic classes
- Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 39822-0615 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 39822-0615 | 39822-0615-2 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A064216-001 | COLISTIMETHATE SODIUM | COLISTIMETHATE SODIUM | EQ 150MG BASE/VIAL | INJECTABLE / INJECTION | | | 1999-02-26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COLISTIMETHATE SODIUM | ACTIVE INGREDIENT | XW0E5YS77G | COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
| COLISTIMETHATE | ACTIVE MOIETY | DL2R53P963 | COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | COLISTIMETHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 22 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 39822-0615-2 | 39822061502 | 12 CARTON in 1 CARTON (39822-0615-2) > 1 VIAL in 1 CARTON (39822-0615-1) > 2 mL in 1 VIAL | 12 carton | 2011-01-01 | 0000-00-00 | No | No | Current |