| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20260526 | 104 |
| These highlights do not include all the information needed to use Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A safely and effectively. See full prescribing information for Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A. Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A Initial U.S. Approval: 1987 Dosage form: Sterile solution Route of administration: Extracorporeal administration from a polyolefin bag | Terumo BCT, Ltd | Terumo BCT, Inc. | 20260521 | 3 |
| SurviveX Travel Med Kit | Intent Brands LLC | 20260507 | 1 |
| These highlights do not include all the information needed to use CLENPIQ ® safely and effectively. See full prescribing information for CLENPIQ. CLENPIQ ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution Initial U.S. Approval: 2012 | Ferring Pharmaceuticals Inc. | 20260415 | 6 |
| Anticoagulant Sodium Citrate | LABORATORIOS GRIFOLS SA | Laboratorios Grifols, S.A. | Laboratorios Grifols, S. A. | 20260414 | 7 |
| Sodium Citrate and Citric Acid Oral Solution, USP | Chartwell Governmental & Specialty RX, LLC | 20260407 | 2 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985 | REMEDYREPACK INC. | 20260406 | 6 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20260325 | 101 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20260325 | 101 |
| Leader Extra Strength Effervescent Antacid & Pain Reliever | Cardinal Health | 20260225 | 3 |
| Potassium Citrate and Citric Acid Oral Solution, USP Rx ONLY | Chartwell Governmental & Specialty RX, LLC. | 20260225 | 2 |
| Tricitrates Oral Solution, USP Rx ONLY | Chartwell Governmental & Specialty RX, LLC. | 20260225 | 1 |
| These highlights do not include all the information needed to use ADDITIVE SOLUTION FORMULA 3 (AS-3) safely and effectively. See full prescribing information for ADDITIVE SOLUTION FORMULA 3 (AS-3). ADDITIVE SOLUTION FORMULA 3 (AS-3) Sterile Fluid Polyolefin Bag Initial U.S. Approval: 2002 | Terumo BCT, Ltd | Terumo BCT, Inc. | 20260130 | 3 |
| Sodium Citrate and Citric Acid Oral Solution USP | Atlantic Biologicals Corp. | 20260128 | 8 |
| EnLyte ® with DeltaFolate TM | Jaymac Pharma | Ocean Healthcare Pvt Ltd | 20260122 | 19 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE Extended-release tablets for oral use Initial U.S. Approval: 1985 | Rising Pharma Holdings, Inc. | Cohance Lifesciences Limited | 20260120 | 5 |
| 87321-001 | Nanjing Hongruixing Biological Technology Co., Ltd | 20260116 | 1 |
| Walgreens Upset Stomach & Nausea Relief Tablets | WALGREENS CO. | 20260115 | 1 |
| Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) with an integral container of Additive Solution (AS-1) preservative, and an integral Leucoflex MTL1 Leukocyte Reduction Filter for Whole Blood | Maco Productions | 20251229 | 15 |
| Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) With an Integral Container of Additive Solution (AS-1) Preservative, And an Integral Leucoflex CGP Leukocyte Reduction Filter for Red Blood Cells | Maco Productions | 20251223 | 6 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985 | ANI Pharmaceuticals, Inc. | 20251222 | 6 |
| CPD - 791-08 | Global Life Sciences Solutions USA LLC | GVS TM INC | GVS TM, INC | 20251218 | 7 |
| E-Z-GAS ® II EFFERVESCENT GRANULES ANTACID/ANTIFLATULENT | E-Z-EM, INC. | Tower Laboratories Ltd | 20251218 | 11 |
| Sterile Cord Blood Collection Unit (MSC127D) | Maco Productions | Maco Productions Polonia sp zoo | 20251218 | 4 |
| Sterile Cord Blood Collection Unit (MSC128D) | Maco Productions | Maco Productions Polonia sp zoo | 20251218 | 4 |
| POTASSIUM CITRATE Extended-Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985 | Biocomp Pharma, Inc. | Mission Pharmacal Company | 20251216 | 11 |
| STERILE CORD BLOOD COLLECTION UNIT (MSC123D) | Maco Productions | 20251216 | 5 |
| CVS Health Chewable Nausea Relief | CVS PHARMACY,INC. | 20251208 | 7 |
| PaxLyte | Jaymac Pharmaceuticals | Ocean Healthcare Pvt Ltd | 20251208 | 5 |
| Alka-Seltzer ® Original | Bayer HealthCare LLC. | 20251204 | 11 |
| Alka-Seltzer Extra Strength | Bayer HealthCare LLC. | 20251204 | 5 |
| Alka-Seltzer Gold | Bayer HealthCare LLC. | 20251204 | 9 |
| Alka-Seltzer Heartburn Effervescent Tablets | Bayer HealthCare LLC. | 20251204 | 6 |
| Urocit ®-K (Potassium Citrate) Extended Release Tablets for Oral Use These highlights do not include all the information needed to use Urocit ® -K safely and effectively. See full prescribing information for Urocit ® -K. Initial U.S. Approval: 1985 | Mission Pharmacal Company | 20251202 | 28 |
| ab19b011-0a51-4f04-9881-d9fc7cae95ae | Fenwal, Inc. | Baxter Healthcare Corporation | 20251125 | 7 |
| Emetrol Chewables Rapid Nausea Relief | WellSpring Pharmaceutical Corporation | 20251120 | 7 |
| Alka-Seltzer ® Original | R J General Corporation | 20251117 | 6 |
| Earthmed Soothe Chewables | Earthmed LLC | 20251114 | 1 |
| 040713e7-67cd-8eb0-e063-6394a90aa2a9 | Aqua Medica, S.A. de C.V. | 20251110 | 3 |
| 040775ab-41bd-cd36-e063-6394a90a08aa | Aqua Medica, S.A. de C.V. | 20251110 | 3 |
| REF PQ610US NDC No. 0942-6550-01 20x Rx only Fresenius Kabi Composelect System with Fenwal HighFlo Needle for Collection of Whole Blood using CPD/Adsol Red Cell Preservation Solution and an Integral Fenwal Bioflex RC Leukocyte Reduction Filter for Filtration of Red Blood Cells. | Fenwal, Inc. | Fresenius Kabi Horatev CZ s.r.o. | 20251105 | 1 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20251104 | 105 |
| Sodium Citrate and Citric Acid Oral Solution USP | Cardinal Health 107, LLC | 20251029 | 6 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE Extended-release tablets for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20251023 | 100 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20251023 | 100 |
| Equate Effervescent Antacid & Pain Relief | Walmart | 20251017 | 6 |
| Walgreens Antacid and Pain Relief Extra Strength Effervescent Tablets | Walgreens | 20251017 | 5 |
| ENL TM plus adenosylcobalamin | Jaymac Pharma | Viva Pharmaceuticals INC | 20251014 | 6 |
| Quality Choice Nausea Relief | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 20251001 | 1 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets for oral use Initial U.S. Approval: 1985 | REMEDYREPACK INC. | 20250912 | 1 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE Extended-release tablets for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20250820 | 102 |
| Medique Medi Seltzer | Unifirst First Aid Corporation | 20250819 | 13 |
| Alka-Seltzer ® Original | Select Consumer Group | 20250818 | 1 |
| POTASSIUM CITRATE 5 and 10 mEq Extended Release Tablets for Oral Use These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate. Initial U.S. Approval: 1985 | Upsher-Smith Laboratories, LLC | Mission Pharmacal Company | 20250714 | 7 |
| Sodium Citrate and Citric Acid Oral Solution USP | Belleview Biosciences LLC | 20250707 | 2 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE Extended-release tablets for oral use Initial U.S. Approval: 1985 | Strides Pharma Inc. | Strides Pharma Science Limited | 20250701 | 10 |
| 800 mL InterSol Solution Platelet Additive Solution 3 with Twist-off Port | Fenwal, Inc. | Fenwal International, Inc. | 20250627 | 2 |
| Nauzene Chewables Ginger Honey | Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC | 20250624 | 2 |
| SODIUM CITRATE AND CITRIC ACID ORAL SOLUTION, USP 500 mg-334 mg/5 mL (1,500 mg-1,002 mg/15 mL Unit Dose) 500 mg-334 mg/5 mL (3,000 mg-2,004 mg/30 mL Unit Dose) Dietary Supplement - FOR INSTITUTIONAL USE ONLY • Alcohol Free • Sugar Free • Cherry Flavor | Rising Pharma Holdings, Inc. | 20250515 | 1 |
| These highlights do not include all the information needed to use PHEXX ® safely and effectively. See full prescribing information for PHEXX. PHEXX (lactic acid, citric acid, and potassium bitartrate) vaginal gel Initial U.S. Approval: 2020 | Evofem, Inc. | 20250502 | 2 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE Extended-release tablets for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20250502 | 102 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE Extended-release tablets for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20250502 | 103 |
| Nauzene Chewables | Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC | 20250429 | 15 |
| Tricitrates Oral Solution, USP Rx ONLY | Chartwell RX, LLC | 20250428 | 6 |
| Sodium Citrate and Ctric Acid Oral Solution, USP | Kesin Pharma Corporation | 20250421 | 2 |
| Potassium Citrate and Citric Acid Oral Solution, USP Rx ONLY | Chartwell RX, LLC | Chartwell Pharmaceuticals Carmel, LLC | 20250409 | 2 |
| Alka-Seltzer Heartburn Relief Lemon Lime | Bayer Healthcare LLC | 20250401 | 9 |
| Alka-Seltzer Heartburn Relief Extra Strength | Bayer Healthcare LLC | 20250311 | 10 |
| 8baab7a7-5d20-46ad-9c4a-762992ef6b51 | Meridian Bioscience Israel Ltd | Taro Pharmaceutical Industries Ltd. | 20250130 | 5 |
| These highlights do not include all the information needed to use SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP safely and effectively. See full prescribing information for SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP. SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP Sterile Fluid Polyolefin Bag Initial U.S. Approval: 1978 | Terumo BCT, Ltd | 20250124 | 2 |
| Anticoagulant Citrate Dextrose Solution, Solution A, USP | Arteriocyte Medical Systems, Inc. | Terumo BCT, Inc. | Terumo BCT, Ltd. | 20250123 | 4 |
| These highlights do not include all the information needed to use SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP safely and effectively. See full prescribing information for SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP. SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP Sterile Fluid Polyvinyl Chloride (PVC) Bag Initial U.S. Approval: 1978 | Terumo BCT, Ltd | 20250123 | 2 |
| Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A | Terumo BCT Ltd | Terumo BCT Ltd. | 20250122 | 5 |
| These highlights do not include all the information needed to use ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A safely and effectively. See full prescribing information for ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A Sterile Fluid Polyolefin Container (solution bag) Clear Overwrap Initial U.S. Approval: 2012 | Terumo BCT, Ltd | Terumo BCT, Inc. | 20250121 | 2 |
| Soothe Chewable Orange | Carolina Cannabis Creations LLC | 20250115 | 2 |
| Soothe Chewable Strawberry | Carolina Cannabis Creations LLC | 20250115 | 2 |
| Soothe Chewable Watermelon | Carolina Cannabis Creations LLC | 20250115 | 3 |
| Soothe Chewables Cherry | Carolina Cannabis Creations LLC | 20250115 | 2 |
| REVEOS ® SELECT SET CPD WITH AS-5 RED CELL PRESERVATIVE SOLUTION FOR COLLECTION OF 500 mL OF BLOOD Terumo BCT, Inc. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use the Reveos SELECT set safely and effectively. See full prescribing information for the Reveos SELECT set. REVEOS SELECT SET Sterile Fluid PVC Plasticized With DEHP Bag Initial U.S. Approval: TBD | Terumo BCT Vietnam CO., Ltd. | Terumo BCT, Ltd. | 20250114 | 3 |
| Sodium Citrate and Citric Acid Oral Solution USP | AvPAK | 20250109 | 2 |
| Emetrol Non-Drowsy Powder Rapid Nausea Relief | WellSpring Pharmaceutical Corporation | 20250108 | 3 |
| These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets for oral use Initial U.S. Approval: 1985 | Bryant Ranch Prepack | 20241224 | 101 |
| 29393313-217a-dc3a-e063-6294a90addb1 | Jiangxi Dentalbright Technology Co., Ltd. | 20241220 | 2 |
| 83778-002 Update | Jiangxi Dentalbright Technology Co., Ltd | 20241220 | 2 |
| Equaline Effervescent Antacid & Pain Relief | United Natural Foods, Inc. dba UNFI | 20241217 | 5 |
| IMUFLEX™ WB-SP BLOOD BAG SYSTEM with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm™ | Terumo Corporation | Terumo Corporation - Fujinomiya Factory | 20241217 | 2 |
| Market Basket Effervescent Antacid & Pain Relief | Demoulas Super Markets, Inc. | 20241217 | 2 |
| Alka-Seltzer ® Heartburn + Pain UI1600130 | Bayer HealthCare LLC. | 20241213 | 1 |
| Best Choice Effervescent Antacid Pain Relief | Valu Merchandisers Company | 20241211 | 3 |
| Effervescent Pain Relief Tablets 36 ct. | Tower Laboratories Ltd | 20241211 | 6 |
| Rite Aid Antacid & Pain Relief | Rite Aid | 20241211 | 4 |
| Potassium Citrate and Citric Acid Oral Solution USP | PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 20241119 | 6 |
| Sal de Uvas Picot ® | RB Health Mexico, S.A. de C.V. | 20241115 | 2 |
| Tricitrates SF Oral Solution | PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 20241115 | 6 |
| CVS Health Extra Strength Effervescent Antacid and Pain Reliever | CVS Pharmacy | 20241114 | 3 |
| CVS Health Original Antacid & Pain Reliever 36 ct. | CVS Pharmacy | 20241114 | 7 |
| Best Choice Effervescent Antacid Pain Relief | Valu Merchandisers Company | 20241113 | 4 |
| Bromo Seltzer | Tower Laboratories Ltd | 20241113 | 7 |
| Care One Original Antacid & Pain Relief | Foodhold U.S.A. | 20241113 | 4 |
| DG Health Effervescent Antacid & Pain Relief | DOLGENCORP, INC | 20241113 | 4 |
| Drug Mart Effervescent Pain Relief | Discount Drug Mart, Inc | 20241113 | 4 |
| Good Sense Effervescent Antacid & Pain Relief | Good Sense | 20241113 | 4 |
| HEB Antacid & Pain Relief | H. E. Butt Grocery Company | 20241113 | 6 |
| Kroger Effervescent Antacid and Pain Relief | Kroger Company | 20241113 | 5 |
| Meijer Effervescent Antacid/Pain Relief | Meijer Distribution Inc | 20241113 | 6 |
| Publix Fast Relief Effervescent | Publix Super Markets Inc. | 20241113 | 5 |
| Quality Choice Effervescent Antacid & Pain Relief | Chain Drug Marketing Association | 20241113 | 5 |
| Quality Choice Effervescent Antacid and Pain Relief Extra Strength | Chain Drug Marketing Association | 20241113 | 3 |
| Signature Care Effervescent Antacid and Pain Relief Tablets | Safeway, Inc | 20241113 | 5 |
| Sodium Citrate and Citric Acid Oral Solution USP | Pharmaceutical Associates, Inc. | 20241113 | 10 |
| Top Care Effervescent Antacid & Pain Relief | Topco Associates LLC | 20241113 | 6 |
| Top Value Effervescent Pain Tablets | Tower Laboratories Ltd | 20241113 | 5 |
| Up and Up Antacid and Pain Relief | Target Corporation | 20241113 | 4 |
| Walgreens Effervescent Pain Relief | Walgreens | 20241113 | 6 |
| WinCo Foods Effervescent Antacid and Pain Relief | WinCo Foods, LLC | 20241113 | 7 |
| These highlights do not include all the information needed to use XENLETA ® safely and effectively. See full prescribing information for XENLETA. XENLETA (lefamulin) injection, for intravenous use XENLETA (lefamulin) tablets, for oral use Initial U.S. Approval: 2019 | Nabriva Therapeutics US, Inc. | Nabriva Therapeutics Ireland DAC | Hovione Limited | Charles River Endotoxin Microbial Detection Europe | HOVIONE FARMACIENCIA, S.A. | Patheon Italia S.p.A | Almac Pharma Services Limited | Sharp Packaging Services, LLC | 20241011 | 9 |
| TERUFLEX™ BLOOD BAG SYSTEM with Diversion Blood Sampling Arm™ CPD/OPTISOL™ SOLUTION For the collection of 450 mL or 500 mL of Whole Blood | Terumo Corporation | Terumo Corp. - Fujinomiya Factory | 20241010 | 1 |
| TERUFLEX™ BLOOD BAG SYSTEM with Diversion Blood Sampling Arm™ CPDA-1 SOLUTION For the collection of 450 mL or 500 mL of Whole Blood | Terumo Corporation | Terumo Corp. - Fujinomiya Factory | 20241010 | 1 |
| TERUFLEX™ BLOOD BAG SYSTEM with Diversion Blood Sampling Arm™ CPD/OPTISOL™ SOLUTION | Terumo Corporation | Terumo Corporation - Fujinomiya Factory | 20241007 | 2 |
| TERUFLEX™ BLOOD BAG SYSTEM with Diversion Blood Sampling Arm™ CPDA-1 SOLUTION For the collection of 450 mL or 500 mL of Whole Blood | Terumo Corporation | Terumo Corp. - Fujinomiya Factory | 20241003 | 1 |