NDC 49230-209 – Delflex
Sodium Chloride 538 mg/100mL; Sodium Lactate 448 mg/100mL; Calcium Chloride 18.4 mg/100mL; Magnesium Chloride 5.08 mg/100mL; Dextrose Monohydrate 2.5 g/100mL · Solution · Intraperitoneal
Product NDC49230-209
Product details
- Brand name
- Delflex
- Generic name
- Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
- Labeler
- Fresenius Medical Care Renal Therapies Group, LLC
- Dosage form
- Solution
- Route
- Intraperitoneal
- Marketing category
- NDA · NDA020171
- Marketed since
- August 19, 1992
- Listing expires
- December 31, 2027
- Pharmacologic class
- Blood Coagulation Factor; Calculi Dissolution Agent; Osmotic Laxative; Osmotic Laxative; Osmotic Laxative; Phosphate Binder
Active ingredients
- Sodium Chloride 538 mg/100mL
- Sodium Lactate 448 mg/100mL
- Calcium Chloride 18.4 mg/100mL
- Magnesium Chloride 5.08 mg/100mL
- Dextrose Monohydrate 2.5 g/100mL
Package NDC codes (8)
| Package NDC | Description | Since |
|---|---|---|
| 49230-209-30 | 4 BAG in 1 CARTON (49230-209-30) / 3000 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-32 | 4 BAG in 1 CARTON (49230-209-32) / 3000 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-50 | 2 BAG in 1 CARTON (49230-209-50) / 5000 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-52 | 2 BAG in 1 CARTON (49230-209-52) / 5000 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-62 | 2 BAG in 1 CARTON (49230-209-62) / 6000 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-92 | 5 BAG in 1 CARTON (49230-209-92) / 2000 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-94 | 5 BAG in 1 CARTON (49230-209-94) / 2500 mL in 1 BAG | Aug 19, 1992 |
| 49230-209-95 | 4 BAG in 1 CARTON (49230-209-95) / 3000 mL in 1 BAG | Aug 19, 1992 |
Recalls mentioning this NDC
- D-0608-2024 Jul 24, 2024 · Class II
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. - D-0218-2024 Jan 10, 2024 · Class II
Lack of Sterility Assurance - D-0607-2021 Jun 16, 2021 · Class III
Temperature Abuse: Product exposed to temperature outside specified limits. - D-0609-2021 Jun 16, 2021 · Class III
Temperature Abuse: Product exposed to temperature outside specified limits. - D-0605-2021 Jun 16, 2021 · Class III
Temperature Abuse: Product exposed to temperature outside specified limits. - D-0610-2021 Jun 16, 2021 · Class III
Temperature Abuse: Product exposed to temperature outside specified limits. - D-0608-2021 Jun 16, 2021 · Class III
Temperature Abuse: Product exposed to temperature outside specified limits. - D-0604-2018 Mar 28, 2018 · Class II
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Other Delflex products
- 46163-206 Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538 mg/100mL;… · Solution · Fresenius Medical Care de Mexico, S.A. de C.V.
- 46163-209 Sodium Chloride 538 mg/100mL; Sodium Lactate 448 mg/100mL; Calcium… · Solution · Fresenius Medical Care de Mexico, S.A. de C.V.
- 46163-212 Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538 mg/100mL;… · Solution · Fresenius Medical Care de Mexico, S.A. de C.V.
- 49230-188 Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 567 mg/100mL;… · Solution · Fresenius Medical Care Renal Therapies Group, LLC
- 49230-191 Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 567 mg/100mL;… · Solution · Fresenius Medical Care Renal Therapies Group, LLC
- 49230-206 Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538 mg/100mL;… · Solution · Fresenius Medical Care Renal Therapies Group, LLC
- 49230-212 Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538 mg/100mL;… · Solution · Fresenius Medical Care Renal Therapies Group, LLC