Colistimethate
- Product NDC
- 25021-159
- 11-digit product format
- 250210159
- Labeler code
- 25021
- Product ID
- 25021-159_bcb0fe18-a09c-4a1c-950b-094471b77bda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colistimethate sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA201365
- Marketing category
- ANDA
- Marketing start
- 2014-12-29
- 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
- 2020-12-31
- 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 | 25021-159 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 25021-159 | 25021-159-10 | 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 |
|---|
| A201365-001 | COLISTIMETHATE SODIUM | COLISTIMETHATE SODIUM | EQ 150MG BASE/VIAL | INJECTABLE / INJECTION | AP | | 2014-02-19 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A201365-001 | AP |
DailyMed Socrata Ingredients#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25021-159-10 | 25021015910 | 1 VIAL in 1 CARTON (25021-159-10) > 2 mL in 1 VIAL | 1 vial | 2014-12-29 | 0000-00-00 | No | No | Current |