ChloraPrep One-Step is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Carefusion 213 Llc. The primary component is Chlorhexidine Gluconate; Isopropyl Alcohol.
| Product ID | 54365-400_7cb2fbbd-5562-4ced-e053-2991aa0afa8d | 
| NDC | 54365-400 | 
| Product Type | Human Otc Drug | 
| Proprietary Name | ChloraPrep One-Step | 
| Generic Name | Chlorhexidine Gluconate And Isopropyl Alcohol | 
| Dosage Form | Solution | 
| Route of Administration | TOPICAL | 
| Marketing Start Date | 2000-07-14 | 
| Marketing Category | NDA / NDA | 
| Application Number | NDA020832 | 
| Labeler Name | CareFusion 213 LLC | 
| Substance Name | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 
| Active Ingredient Strength | 20 mg/mL; mL/mL | 
| NDC Exclude Flag | N | 
| Listing Certified Through | 2019-12-31 | 
| Marketing Start Date | 2009-06-10 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| Marketing Category | NDA | 
| Application Number | NDA021555 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2005-05-10 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2002-04-26 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2000-07-14 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA021555 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2002-10-07 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2006-08-18 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2014-07-23 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2006-08-18 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2014-01-07 | 
| Marketing End Date | 2014-01-23 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2002-04-26 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2006-08-18 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2000-07-14 | 
| Marketing Category | NDA | 
| Application Number | NDA021555 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2009-06-10 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2002-04-26 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2019-05-24 | 
| Marketing Category | NDA | 
| Application Number | NDA020832 | 
| Product Type | HUMAN OTC DRUG | 
| Marketing Start Date | 2000-07-14 | 
| Ingredient | Strength | 
|---|---|
| CHLORHEXIDINE GLUCONATE | 20 mg/mL | 
| SPL SET ID: | 3f94d971-0d96-47a2-9117-540dfd1278a6 | 
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | 
| NDC | Brand Name | Generic Name | 
|---|---|---|
| 54365-400 | ChloraPrep One-Step | chlorhexidine gluconate and isopropyl alcohol | 
| 17518-080 | 3M SoluPrep | chlorhexidine gluconate and isopropyl alcohol | 
| 17518-081 | 3M SoluPrep | chlorhexidine gluconate and isopropyl alcohol | 
| 0234-0587 | Hibistat | Chlorhexidine gluconate and Isopropyl alcohol | 
| 10819-4075 | Prevantics Maxi Swabstick | chlorhexidine gluconate and isopropyl alcohol | 
| 10819-4076 | Prevantics Maxi Swabstick | chlorhexidine gluconate and isopropyl alcohol | 
| 10819-1080 | Prevantics Swab | Chlorhexidine Gluconate and Isopropyl Alcohol | 
| 10819-4077 | Prevantics Swabstick | chlorhexidine gluconate and isopropyl alcohol |