NDC 54365-400 – ChloraPrep One-Step
Chlorhexidine Gluconate 20 mg/mL; Isopropyl Alcohol .7 mL/mL · Solution · Topical
Product NDC54365-400
Product details
- Brand name
- ChloraPrep One-Step
- Generic name
- Chlorhexidine gluconate and isopropyl alcohol
- Labeler
- CareFusion 213, LLC
- Dosage form
- Solution
- Route
- Topical
- Marketing category
- NDA · NDA020832
- Marketed since
- May 24, 2019
- Listing expires
- December 31, 2026
Active ingredients
- Chlorhexidine Gluconate 20 mg/mL
- Isopropyl Alcohol .7 mL/mL
Uses, dosage, side effects and warnings for ChloraPrep One-Step →
Package NDC codes (12)
| Package NDC | Description | Since |
|---|---|---|
| 54365-400-07 | 48 POUCH in 1 CARTON (54365-400-07) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR | May 10, 2005 |
| 54365-400-08 | 40 POUCH in 1 CARTON (54365-400-08) / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR | Jun 10, 2009 |
| 54365-400-30 | 20 POUCH in 1 CARTON (54365-400-30) / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-31 | 60 POUCH in 1 CARTON (54365-400-31) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-32 | 25 POUCH in 1 CARTON (54365-400-32) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-33 | 25 POUCH in 1 CARTON (54365-400-33) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-34 | 25 POUCH in 1 CARTON (54365-400-34) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-35 | 25 POUCH in 1 CARTON (54365-400-35) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-36 | 25 POUCH in 1 CARTON (54365-400-36) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-37 | 1 APPLICATOR in 1 POUCH (54365-400-37) / 26 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-38 | 1 APPLICATOR in 1 POUCH (54365-400-38) / 26 mL in 1 APPLICATOR | May 24, 2019 |
| 54365-400-39 | 1 APPLICATOR in 1 POUCH (54365-400-39) / 26 mL in 1 APPLICATOR | May 24, 2019 |
Recalls mentioning this NDC
- D-0690-2026 Jul 22, 2026 · Class II
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator - D-0643-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0652-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0649-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0648-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0647-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0651-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0646-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0645-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0650-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended…