B. Braun Medical Inc

FDA Drug Class II Ongoing

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

August 26, 2025 B. Braun Medical Inc 26,316 3000 mL bags units

FDA Drug Class II Ongoing

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

August 26, 2025 B. Braun Medical Inc 16,228 3000 mL bags units

FDA Drug Class I Ongoing

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

August 18, 2025 B. Braun Medical Inc 47,148 containers units

FDA Drug Class I Ongoing

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

August 18, 2025 B. Braun Medical Inc 46,032 containers units

FDA Drug Class II Ongoing

0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.

August 4, 2025 B. Braun Medical Inc 23,100 containers units

FDA Drug Class II Ongoing

Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

August 4, 2025 B. Braun Medical Inc 74,088 containers units

FDA Drug Class II Ongoing

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

June 16, 2025 B. Braun Medical Inc 187,656 containers units

FDA Drug Class II Ongoing

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

March 31, 2025 B. Braun Medical Inc 32,256 Bottles units

FDA Drug Class I Ongoing

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

July 24, 2024 B. Braun Medical Inc 63,444 containers units

FDA Drug Class II Terminated

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

March 22, 2024 B. Braun Medical Inc 7,800 bags units

FDA Drug Class II Terminated

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20

March 6, 2024 B. Braun Medical Inc 22,752 bags units

FDA Drug Class III Terminated

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

August 2, 2023 B. Braun Medical Inc 43,812 bags units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

July 5, 2023 B. Braun Medical Inc 79,880 bags units

FDA Drug Class II Terminated

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

May 9, 2023 B. Braun Medical Inc 1,380 units

FDA Drug Class II Terminated

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

March 1, 2023 B. Braun Medical Inc 30672 units

FDA Drug Class II Completed

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

February 10, 2023 B. Braun Medical Inc 1,343,982 bags units

FDA Drug Class II Completed

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10

February 10, 2023 B. Braun Medical Inc 483,229 bags units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

November 25, 2022 B. Braun Medical Inc 756 bags units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

February 25, 2022 B. Braun Medical Inc 33,742 bags units

FDA Drug Class I Terminated

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

April 18, 2020 B. Braun Medical Inc 22,488 Duplex containers units

FDA Drug Class II Terminated

Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, ND

June 13, 2019 B. Braun Medical Inc 40,176 bags units

FDA Drug Class II Terminated

0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.

February 16, 2018 B. Braun Medical Inc 17,360 plastic irrigation containers units

FDA Drug Class II Terminated

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

December 15, 2017 B. Braun Medical Inc 2,576 containers units

FDA Drug Class I Terminated

5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

March 25, 2016 B. Braun Medical Inc 57,408 units units

FDA Drug Class II Terminated

0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.

November 27, 2013 B. Braun Medical Inc 19,572 bags units

FDA Drug Class I Terminated

TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55

November 21, 2013 B. Braun Medical Inc 17,544 units units

FDA Drug Class I Terminated

Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11

November 21, 2013 B. Braun Medical Inc 42,576 units units

FDA Drug Class I Terminated

0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31

November 21, 2013 B. Braun Medical Inc 53,592 units units

FDA Drug Class I Terminated

0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55

November 21, 2013 B. Braun Medical Inc 1302 units units

FDA Drug Class I Terminated

Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-58

November 21, 2013 B. Braun Medical Inc 22,248 units units

FDA Drug Class I Terminated

Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-

November 21, 2013 B. Braun Medical Inc 136,392 units units

FDA Drug Class I Terminated

Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-

November 21, 2013 B. Braun Medical Inc 22,584 units units

FDA Drug Class I Terminated

Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895

November 21, 2013 B. Braun Medical Inc 32,376 units units

FDA Drug Class I Terminated

Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Sc

November 21, 2013 B. Braun Medical Inc 5,592 units units

FDA Drug Class I Terminated

6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-

November 21, 2013 B. Braun Medical Inc 4614 units units

FDA Drug Class I Terminated

ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0

November 21, 2013 B. Braun Medical Inc 18,090 units units

FDA Drug Class I Terminated

15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc.,

November 21, 2013 B. Braun Medical Inc 18,288 units units

FDA Drug Class I Terminated

Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc.

October 15, 2013 B. Braun Medical Inc 18,936 Containers units