| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947 | SpecGx LLC | 20260428 | 10 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets , for oral use, CII Initial U.S. Approval: 1947 | SpecGx LLC | 20260427 | 47 |
| These highlights do not include all the information needed to use METHADOSE safely and effectively. See full prescribing information for METHADOSE. METHADOSE (methadone hydrochloride) oral concentrate, CII Initial U.S. Approval: 1947 | SpecGx LLC | 20260427 | 41 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947 | Bryant Ranch Prepack | 20260409 | 104 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | Ascend Laboratories, LLC | Aavis Pharmaceuticals | 20260401 | 4 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947 | Bryant Ranch Prepack | 20260331 | 106 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. Methadone Hydrochloride Oral Solution, for oral use, CII Initial U.S. Approval: 1947 | VistaPharm, LLC | 20260319 | 32 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, CII Initial U.S. Approval: 1947 | Hikma Pharmaceuticals USA | West-Ward Columbus Inc. | 20260303 | 18 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE . METHADONE HYDROCHLORIDE oral concentrate, CII Initial U.S. Approval: 1947 | VistaPharm, LLC | 20260213 | 24 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION. METHADONE HYDROCHLORIDE tablets for oral suspension, for oral use, CII Initial U.S. Approval: 1947 | VistaPharm, LLC | 20260127 | 21 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947 | Lannett Company, Inc. | 20260112 | 20 |
| 092d78eb-6423-495c-bf0d-e6532bea7138 | Mylan Institutional LLC | 20251231 | 16 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | VistaPharm, LLC | 20251231 | 17 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | VistaPharm, LLC | 20251231 | 15 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | Major Pharmaceuticals | 20251226 | 4 |
| These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 | Aurolife Pharma, LLC | 20251223 | 18 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS . METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947 | Epic Pharma, LLC | 20251208 | 15 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE Tablets, for oral use, CII Initial U.S. Approval: 1947 | Elite Laboratories, Inc. | 20251208 | 12 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | Siegfried USA LLC | 20251205 | 23 |
| These highlights do not include all the information needed to use DISKETS safely and effectively. See full prescribing information for DISKETS. DISKETS (methadone hydrochloride) tablets, for oral suspension CII Initial U.S. Approval: 1947 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20251201 | 19 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947 | Precision Dose, Inc. | 20251105 | 5 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20251031 | 9 |
| METHADONE HYDROCHLORIDE INJECTION, USP CII 200 mg/20 mL (10 mg/mL) | Breckenridge Pharmaceutical Inc | Siegfried USA, LLC | Quality Chemical Laboratories | Pine Lake Investments Inc. | Alcami Carolinas Corporation | 20250909 | 2 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | Camber Pharmaceuticals, Inc | Ascent Pharmaceuticals, Inc | 20250828 | 7 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, CII Initial U.S. Approval: 1947 | SpecGx LLC | 20250725 | 7 |
| METHADONE HYDROCHLORIDE INJECTION, USP CII 200 mg/20 mL (10 mg/mL) | Long Grove Pharmaceuticals, LLC | 20250620 | 2 |
| METHADONE HYDROCHLORIDE INJECTION, USP CII 200 mg/20 mL (10 mg/mL) Rx only | Hikma Pharmaceuticals USA Inc. | 20250617 | 1 |
| 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only | ATLANTIC BIOLOGICALS CORP. | 20250603 | 6 |
| 1927-METHADONE HYDROCHLORIDE ORAL CONCENTRATE These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947 | Atlantic Biologicals Corp. | 20250529 | 1 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947 | American Health Packaging | 20250513 | 3 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, CII Initial U.S. Approval: 1947 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20250401 | 11 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947 | Precision Dose, Inc. | 20250108 | 2 |
| METHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY | ATLANTIC BIOLOGICALS CORP. | 20240724 | 8 |
| METHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY | ATLANTIC BIOLOGICALS CORP. | 20240524 | 3 |
| Methadone HCl Oral Concentrate | ATLANTIC BIOLOGICALS CORP. | 20240521 | 3 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947 | ATLANTIC BIOLOGICALS CORP. | 20240520 | 5 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CII Initial U.S. Approval: 1947 | XLCare Pharmaceuticals, Inc | Ascent Pharmaceuticals, Inc | 20240111 | 3 |
| These highlights do not include all the information needed to use METHADOSE ™ DISPERSIBLE TABLETS and METHADONE HYDROCHLORIDE TABLETS for oral suspension safely and effectively. See full prescribing information for METHADOSE DISPERSIBLE TABLETS and METHADONE HYDROCHLORIDE TABLETS for oral suspension. METHADOSE ™ (methadone hydrochloride), dispersible tablets, for oral suspension, CII METHADONE HYDROCHLORIDE tablets for oral suspension, CII Initial U.S. Approval: 1947 | SpecGx LLC | 20231201 | 35 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947 | Bryant Ranch Prepack | 20231106 | 4 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 | ATLANTIC BIOLOGICALS CORP. | 20231102 | 15 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947 | ATLANTIC BIOLOGICALS CORP. | 20230601 | 2 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947 | ATLANTIC BIOLOGICALS CORP. | 20230413 | 2 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947 | Bryant Ranch Prepack | 20230126 | 10 |
| Methadone Hydrochloride Injection, USP CII 200 mg/20 mL (10 mg/mL) | Akorn | 20220701 | 9 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947 | Ascend Laboratories, LLC | Alkem Laboratories | 20220613 | 11 |
| METHADONE HYDROCHLORIDE | Direct_Rx | 20200120 | 2 |
| Methadone Hydrochloride Oral Concentrate USP CII, 10 mg per mL (Dye-Free, Sugar-Free, Unflavored) | Lohxa | 20190910 | 2 |
| METHADONE HYDROCHLORIDE | Direct_Rx | 20190723 | 1 |
| These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE INTENSOL TM (ORAL CONCENTRATE) safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE INTENSOL TM (ORAL CONCENTRATE) METHADONE HYDROCHLORIDE Intensol TM (oral concentrate), for oral use, CII Initial U.S. Approval: 1947 | ATLANTIC BIOLOGICALS CORP. | 20181031 | 1 |
| METHADONE HYDROCHLORIDE | DIRECT RX | 20160606 | 2 |
| Methadone Hydochloride 10mg | Lake Erie Medical DBA Quality Care Products LLC | 20131010 | 3540 |
| METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only | STAT Rx USA LLC | PSS World Medical Inc. | 20120420 | 1 |
| METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only | H.J. Harkins Company Inc. | Mallinckrodt Inc. | 20111208 | 3 |
| ec41ab86-a948-44e4-b21c-c65a22cdf294 | STAT Rx USA LLC | 20111105 | 1 |
| cf10ec82-1f41-45c0-b438-5ade38b5625a | Physicians Total Care, Inc. | 20100614 | 1 |
| METHADONE HYDROCHLORIDE INJECTION, USP | Xanodyne Pharmaceuticals Inc. | 20071006 | 1 |