Application 017386
- Type
- NDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZAROXOLYN | METOLAZONE | TABLET;ORAL | 2.5MG | Yes | No |
| 002 | ZAROXOLYN | METOLAZONE | TABLET;ORAL | 5MG | Yes | Yes |
| 003 | ZAROXOLYN | METOLAZONE | TABLET;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017386-001 | ZAROXOLYN | METOLAZONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017386-002 | ZAROXOLYN | METOLAZONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017386-003 | ZAROXOLYN | METOLAZONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017386-002 | ZAROXOLYN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017386-003 | ZAROXOLYN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017386-001 | ZAROXOLYN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N017386-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N017386-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N017386-003 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017386-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017386-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017386-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N017386-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N017386-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N017386-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N017386-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N017386-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N017386-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N017386-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N017386-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N017386-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N017386-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N017386-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N017386-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N017386-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N017386-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N017386-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N017386-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N017386-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N017386-003 | AB | 1 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 27ab833e-b809-4a80-b7fc-b3599f1751d3 | 2026-07-22 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 8fef500f-7855-46ed-a51e-412708505a0e | 2026-07-22 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Golden State Medical Supply, Inc. | c67c00c9-2c2c-6223-e053-2995a90a7291 | 2026-05-28 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Amici Pharma, Inc | cbfa3d5c-cce9-4afa-b064-06f1e1041eac | 2026-04-01 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 7df08bbb-0ab8-485c-8994-48ecadd096f1 | 2026-03-17 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Safecor Health LLC | efa8795e-2c89-4519-b49f-13146fb9ded1 | 2026-03-02 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Method Pharmaceuticals, LLC | 1a8c38aa-362e-6bcc-e063-6294a90a1e05 | 2026-02-11 | Warnings, Adverse reactions | METOLAZONE |
| METOLAZONE | METOLAZONE | Advagen Pharma Limited | 6a9c8415-e389-7a9a-73de-532cf3f57ac5 | 2026-01-15 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Unichem Pharmaceuticals (USA), Inc. | c6fe5426-a184-44b8-a555-621d72aa5b9f | 2025-12-11 | Warnings, Adverse reactions | METOLAZONE |
| METOLAZONE | METOLAZONE | Aarkish Pharmaceuticals NJ Inc. | 51300edb-2b0f-427c-aeed-bc74a12f52ce | 2025-12-08 | Warnings, Adverse reactions | METOLAZONE |
| METOLAZONE | METOLAZONE | Marlex Pharmaceuticals, Inc. | efa5244a-9cdf-a806-e053-2a95a90a912e | 2025-11-21 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Major Pharmaceuticals | 89201e19-d0e8-4192-b2a1-150e9d2c104d | 2025-11-20 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 2125b330-eb56-4310-9806-e101eae4576c | 2025-10-21 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Ingenus Pharmaceuticals LLC | 1e566c10-4498-4f79-8874-4cc8c4216213 | 2025-10-08 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Mylan Institutional Inc. | e5fe856e-7fd6-47fb-87f7-7c1c621f50a0 | 2025-07-22 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Major Pharmaceuticals | 8e8bbe58-0845-40d1-9831-82435f01c7be | 2025-07-22 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 3be4e158-e486-44db-9be7-dc72fdc2dbc7 | 2025-05-12 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 34f91465-7a97-e543-e063-6294a90a1ac7 | 2025-05-12 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Sandoz Inc | 0b619826-2567-49d7-8972-b6da5e4467df | 2025-03-19 | Warnings, Adverse reactions | METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 08cb093a-b8ec-40d9-b292-2513b488d14c | 2024-12-24 | Warnings, Adverse reactions | METOLAZONE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-2215 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2215 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2215 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2215 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2216 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2216 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2216 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2216 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2217 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2217 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2217 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-2217 | metolazone | metolazone | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0904-6915 | metolazone | metolazone | Major Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 0904-6915 | metolazone | metolazone | Major Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 0904-6915 | metolazone | metolazone | Major Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 0904-6916 | metolazone | metolazone | Major Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 0904-6916 | metolazone | metolazone | Major Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 43353-999 | Metolazone | metolazone | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 60687-536 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-536 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-536 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-536 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-547 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-547 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-547 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-547 | Metolazone | Metolazone | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 65580-643 | metolazone | metolazone | Upstate Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 65580-644 | metolazone | metolazone | Upstate Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 65580-645 | metolazone | metolazone | Upstate Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 68151-2943 | Zaroxolyn | metolazone | Carilion Materials Management | NDA | Current |
| 71610-142 | metolazone | metolazone | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 76519-1166 | METOLAZONE | METOLAZONE | H.J. Harkins Co., Inc. | NDA | Current |