Coly-Mycin
- Product NDC
- 42023-107
- 11-digit product format
- 420230107
- Labeler code
- 42023
- Product ID
- 42023-107_c8e9dd7e-ffbc-4d56-bdb7-fd41951bcee6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colistimethate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Endo USA, Inc.
- Application
- NDA050108
- Marketing category
- NDA
- Marketing start
- 2007-11-01
- 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
- Coly-Mycin
- Brand name suffix
- M
- 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, 1117525 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42023-107-01 | Coly-MycinM | 1 in 1 CARTON | INJECTION | 1 | | 26 |
| 42023-107-01 | Coly-MycinM | 2 mL in 1 VIAL | INJECTION | 2 | | 26 |
| 42023-107-06 | Coly-MycinM | 6 in 1 CARTON | INJECTION | 6 | | 26 |
| 42023-107-06 | Coly-MycinM | 2 mL in 1 VIAL | INJECTION | 2 | | 26 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-107 | COLY-MYCIN M (COLISTIMETHATE) INJECTION [ENDO USA, INC.] | 22 | Current NDC, Legacy NDC, 4 package rows | 20241114_6d6e13e2-dc33-4b7b-84d0-66146a57c552.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 |
|---|
| 42023-107-01 | 42023010701 | 1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL | 1 vial | 2007-11-01 | 0000-00-00 | No | No | Current |
| 42023-107-06 | 42023010706 | 6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL | 6 vial | 2007-11-01 | 2022-10-31 | No | No | Current |