| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260522 | 34 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260522 | 19 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260522 | 20 |
| Promethazine Hydrochloride Tablets USP | Sportpharm LLC | 20260424 | 2 |
| Promethazine Hydrochloride Tablets USP | REMEDYREPACK INC. | 20260423 | 21 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | NuCare Pharmaceuticals,Inc. | 20260423 | 4 |
| Promethazine with Dextromethorphan Cough Syrup | Atlantic Biologicals Corp. | 20260423 | 1 |
| Promethazine Syrup Plain 6.25 mg/5 mL (Promethazine Hydrochloride Oral Solution, USP) | Atlantic Biologicals Corp. | 20260416 | 1 |
| Promethazine Hydrochloride Tablets, USP (12.5 mg, 25 mg and 50 mg) Rx only | A-S Medication Solutions | 20260327 | 5 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Bryant Ranch Prepack | 20260320 | 103 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only | PD-Rx Pharmaceuticals, Inc. | 20260319 | 17 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | KVK-Tech, Inc. | 20260313 | 13 |
| Promethazine HCL | Direct_Rx | 20260305 | 3 |
| PROMETHAZINE HYDROCHLORIDE | DIRECT RX | 20260305 | 7 |
| Promethazine Hydrochloride Injection, USP Rx Only | Henry Schein, Inc. | 20260305 | 6 |
| Promethazine Hydrochloride Tablets USP | REMEDYREPACK INC. | 20260206 | 10 |
| PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP | Chartwell RX, LLC | 20260130 | 4 |
| Promethazine Hydrochloride Injection, USP | Cardinal Health 107, LLC | 20260115 | 9 |
| These highlights do not include all the information needed to use PROMETHAZINE and PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE and PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE and PHENYLEPHRINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC | 20260108 | 36 |
| Promethazine Hydrochloride Tablets USP Revised: December 2016 Rx Only | Northwind Health Company, LLC | 20260101 | 2 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | Northwind Health Company, LLC | 20260101 | 3 |
| Promethazine Hydrochloride Tablets, USP (25 mg) Rx only | Northwind Health Company, LLC | 20260101 | 3 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only | Northwind Health Company, LLC | 20251226 | 3 |
| Promethazine Hydrochloride Tablets, USP (12.5 mg, 25 mg and 50 mg) Rx only | Amneal Pharmaceuticals of New York LLC | Amneal Pharmaceuticals Private Limited | 20251220 | 18 |
| Promethazine Hydrochloride Injection, USP | ProPharma Distribution | 20251218 | 3 |
| These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Cosette Pharmaceuticals, Inc. | Tris Pharma Inc | 20251218 | 1 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Cranbury Pharmaceuticals, LLC | 20251212 | 13 |
| Promethazine HCL Syrup | Cranbury Pharmaceuticals, LLC | 20251212 | 7 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Cranbury Pharmaceuticals, LLC | 20251212 | 10 |
| Promethazine HCL Syrup | ATLANTIC BIOLOGICALS CORP | 20251211 | 4 |
| Promethazine Hydrochloride Injection, USP | ProPharma Distribution | 20251211 | 1 |
| Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg | A-S Medication Solutions | 20251204 | 22 |
| PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP | Chartwell Governmental & Specialty RX, LLC. | 20251121 | 1 |
| Promethazine Hydrochloride Tablets USP 8015401/0224 Rx only | American Health Packaging | 20251113 | 10 |
| Promethazine Hydrochloride Tablets, USP Rx Only 8466001/0224F | American Health Packaging | 20251113 | 3 |
| Promethazine HCL 25 mg/mL Injection, USP 1 mL Single Dose Ampule | Henry Schein, Inc. | 20251107 | 6 |
| Promethazine HCL 50 mg/mL Injection, USP 1 mL Single Dose Ampule | Henry Schein, Inc. | 20251107 | 6 |
| Promethazine Hydrochloride Tablets, USP (12.5 mg, 25 mg and 50 mg) Rx only | Cardinal Health 107, LLC | 20251024 | 2 |
| Promethazine Hydrochloride Tablets USP | ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM | 20251021 | 1 |
| PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only | PD-Rx Pharmaceuticals, Inc. | 20251020 | 14 |
| Promethazine Hydrochloride Suppositories USP, 25 mg | PD-Rx Pharmaceuticals, Inc. | 20251015 | 18 |
| Promethazine Hydrochloride Tablets, USP | REMEDYREPACK INC. | 20251003 | 3 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg and 15 mg per 5 mL Rx Only | Cosette Pharmaceuticals, Inc. | 20250923 | 1 |
| Promethazine with Dextromethorphan Cough Syrup | A-S Medication Solutions | 20250923 | 1 |
| Promethazine Hydrochloride Tablets, USP (12.5 mg, 25 mg and 50 mg) Rx only | Major Pharmaceuticals | 20250922 | 3 |
| Promethazine DM Oral Solution | Preferred Pharmaceuticals Inc. | 20250916 | 5 |
| Promethazine Hydrochloride Tablets USP | Preferred Pharmaceuticals Inc. | 20250916 | 5 |
| Promethazine Hydrochloride Tablets, USP | BluePoint Laboratories | Zydus Pharmaceuticals (USA) Inc. | Cadila Healthcare Limited, Baddi | 20250912 | 9 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Rx Only | ANI Pharmaceuticals, Inc. | 20250808 | 3 |
| Promethazine Plain Oral Solution (Promethazine Hydrochloride Oral Solution, USP) Rx Only | PAI Holdings, LLC dba PAI Pharma | 20250805 | 11 |
| PHENERGAN Injection (promethazine hydrochloride injection, USP) | Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A | 20250630 | 8 |
| Promethazine Hydrochloride Injection, USP | Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A | 20250630 | 5 |
| Promethazine Hydrochloride Injection, USP | Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A | 20250630 | 6 |
| Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20250607 | 1 |
| 0065-PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | ATLANTIC BIOLOGICALS CORP. | 20250604 | 3 |
| Promethazine DM Oral Solution | PAI Holdings, LLC dba PAI Pharma | 20250531 | 1 |
| Promethazine DM Oral Solution | ATLANTIC BIOLOGICALS CORP. | 20250523 | 3 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Rx Only | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20250507 | 2 |
| Promethazine Syrup Plain 6.25 mg/5 mL (Promethazine Hydrochloride Oral Solution, USP) | Xttrium Laboratories, Inc. | Halo Pharmaceutical Canada Inc. | 20250407 | 1 |
| Promethazine with Dextromethorphan Cough Syrup | Xttrium Laboratories, Inc | Xttrium Laboratories, Inc. | Halo Pharmaceutical Canada Inc. | 20250407 | 1 |
| Promethazine Hydrochloride Oral Solution USP 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) | Kesin Pharma Corporation | 20250313 | 5 |
| Promethazine Hydrochloride Oral Solution USP 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) | Nostrum Laboratories, Inc. | 20250312 | 4 |
| Promethazine Hydrochloride Tablets USP Revised: December 2016 Rx Only | NuCare Pharmaceuticals,Inc. | 20250210 | 5 |
| Promethazine Hydrochloride Tablets, USP | Coupler LLC | Zydus Pharmaceuticals (USA) Inc. | 20250207 | 1 |
| Promethazine DM Oral Solution | NuCare Pharmaceuticals,Inc. | 20250203 | 2 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | NuCare Pharmaceuticals,Inc. | 20250108 | 3 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only | PD-Rx Pharmaceuticals, Inc. | 20250107 | 23 |
| Promethazine Hydrochloride Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 20241231 | 2 |
| Promethazine DM Oral Solution | Slate Run Pharmaceuticals, LLC | TriRx Huntsville Pharmaceutical Services, LLC | 20241204 | 4 |
| Promethazine Hydrochloride Tablets USP | Zydus Lifesciences Limited | 20241204 | 7 |
| Promethazine Hydrochloride Tablets USP | Coupler LLC | 20241112 | 1 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Amneal Pharmaceuticals LLC | 20241030 | 13 |
| PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTION, USP 6.25 mg and 5 mg/5 mL Rx Only | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC | 20241030 | 12 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | 20241030 | 19 |
| Promethazine Hydrochloride Tablets USP | A-S Medication Solutions | 20241021 | 8 |
| Promethazine Hydrochloride Tablets USP | A-S Medication Solutions | 20241021 | 8 |
| Promethazine Hydrochloride Tablets USP | A-S Medication Solutions | 20241021 | 5 |
| Promethazine Hydrochloride Tablets USP | NuCare Pharmaceuticals,Inc. | 20240926 | 6 |
| Promethazine Hydrochloride Tablets, USP Rx only | NCS HealthCare of KY, LLC dba Vangard Labs | 20240913 | 4 |
| Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL Rx only | Bryant Ranch Prepack | 20240815 | 101 |
| Promethazine Hydrochloride Tablets USP | Bryant Ranch Prepack | 20240808 | 7 |
| Promethazine Hydrochloride Oral Solution USP 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) | Bryant Ranch Prepack | 20240730 | 100 |
| Promethazine Hydrochloride and Phenylephrine Hydrochloride Oral Solution | Genus Lifesciences Inc. | 20240722 | 1 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | Bryant Ranch Prepack | 20240709 | 103 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | Bryant Ranch Prepack | 20240709 | 7 |
| 40d4ef22-f12f-0667-e054-00144ff8d46c | RedPharm Drug, Inc. | 20240702 | 6 |
| Promethazine Hydrochloride Tablets USP | NuCare Pharmaceuticals,Inc. | 20240614 | 6 |
| Promethazine 25mg | RedPharm Drug, Inc. | 20240613 | 5 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | NuCare Pharmaceuticals,Inc. | 20240612 | 3 |
| Promethazine Hydrochloride Injection, USP | Hikma Pharmaceuticals USA Inc. | 20240605 | 14 |
| PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP | ATLANTIC BIOLOGICALS CORP. | 20240605 | 5 |
| PHENERGAN Injection (promethazine hydrochloride Injection, USP) Rx only | Hikma Pharmaceuticals USA Inc. | 20240520 | 8 |
| PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP) | ATLANTIC BIOLOGICALS CORP. | 20240515 | 5 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Bryant Ranch Prepack | 20240416 | 104 |
| Promethazine Hydrochloride Injection, USP | Hikma Pharmaceuticals USA Inc. | 20240410 | 4 |
| Promethazine Hydrochloride Injection, USP Rx only NOVAPLUS® | Hikma Pharmaceuticals USA Inc. | 20240410 | 10 |
| Promethazine Hydrochloride Tablets USP | Bryant Ranch Prepack | 20240402 | 1023 |
| Promethazine Hydrochloride Tablets USP | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20240226 | 1 |
| PROMETHAZINE HCI INJECTION, USP 25mg/mL 1mL VIAL | HF Acquisition Co. LLC, DBA HealthFirst | 20240222 | 7 |
| PROMETHAZINE HCI INJECTION, USP 50mg/mL 1mL AMPULE | HF Acquisition Co. LLC, DBA HealthFirst | 20240222 | 7 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | A-S Medication Solutions | 20240212 | 5 |
| Promethazine Hydrochloride Injection, USP | XGen Pharmaceuticals DJB, Inc. | 20240109 | 6 |
| Promethazine Hydrochloride Injection, USP | XGen Pharmaceuticals DJB, Inc. | 20240105 | 8 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | A-S Medication Solutions | 20231215 | 3 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | A-S Medication Solutions | 20231215 | 3 |
| PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only | Cosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC | 20231130 | 7 |
| PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only | Cosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC | 20231130 | 7 |
| Promethazine Hydrochloride | Marlex Pharmaceuticals Inc | 20231122 | 8 |
| Promethazine Hydrochloride Tablets USP | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20231107 | 8 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | A-S Medication Solutions | 20231024 | 5 |
| Promethazine HCL Syrup | A-S Medication Solutions | 20230910 | 2 |
| Promethazine DM Oral Solution | A-S Medication Solutions | 20230810 | 2 |
| Promethazine with Dextromethorphan Cough Syrup (Promethazine Hydrochloride 6.25 mg/5 mL & Dextromethorphan Hydrobromide 15 mg/5 mL) Rx only | A-S Medication Solutions | 20230711 | 2 |
| Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg | Padagis Israel Pharmaceuticals Ltd | 20230630 | 16 |
| Promethazine/Codeine | Direct_Rx | 20230602 | 1 |
| Promethazine Hydrochloride Injection, USP | Medical Purchasing Solutions, LLC | 20230523 | 3 |
| PROMETHAZINE HYDROCHLORIDE TABLETS, USP | A-S Medication Solutions | 20230508 | 10 |
| Promethazine Hydrochloride Injection, USP | Medical Purchasing Solutions, LLC | 20230502 | 2 |
| Promethazine Hydrochloride Tablets USP | Proficient Rx LP | 20230501 | 1 |
| PROMETHAZINE HYDROCHLORIDE | Direct_Rx | 20230412 | 4 |