Application 018687
- Type
- NDA
- Sponsor
- SCHERING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018687-001 | NORMODYNE | LABETALOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | |
| N018687-002 | NORMODYNE | LABETALOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | |
| N018687-003 | NORMODYNE | LABETALOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | |
| N018687-004 | NORMODYNE | LABETALOL HYDROCHLORIDE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018687-001 | NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018687-002 | NORMODYNE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018687-003 | NORMODYNE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018687-004 | NORMODYNE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Method Pharmaceuticals, LLC | 733d6e32-ac90-4796-bf25-9d5887c897a5 | 2025-12-23 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 99a715a0-4579-410c-b102-7ef6fab8db55 | 2025-12-19 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Redpharm Drug | 32525ed4-3cca-2b99-e063-6294a90a6c66 | 2025-12-13 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Chartwell RX, LLC | ac439c08-1e47-4306-8308-b31d7a1a443c | 2025-12-02 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Mullan Pharmaceutical Inc. | fb5ef3ba-0a7e-4f41-9547-d734983da0d3 | 2025-12-01 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | e6836a01-220d-4b69-9b4a-c919daeb6ece | 2025-11-20 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 0dcd514d-bda8-484b-8cf1-f5656aaab9ce | 2025-10-29 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 20c26652-52da-4eef-8486-f91eb30e9ff7 | 2025-10-29 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | dafa7411-2857-4f5a-a587-4367cfbe2bfa | 2025-10-23 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Amneal Pharmaceuticals LLC | dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc | 2025-10-06 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 366134cd-6244-45fc-99f1-0193a0221b3a | 2025-10-06 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | RedPharm Drug | 1e1b7355-4802-d277-e063-6394a90aef44 | 2025-07-29 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | NuCare Pharmaceuticals , Inc. | 3aff731f-1eec-19b5-e063-6294a90a3143 | 2025-07-28 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol HCL | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 312dde0d-5147-483e-968f-4e0d46114176 | 2025-06-19 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Caplin Steriles Limited | 77152699-1ca8-442a-8cb4-80b0ffbec6f2 | 2025-02-14 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 5faacbcc-f88f-42f7-8702-791ee82c4d18 | 2025-01-09 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | American Health Packaging | 3004aa59-288c-4971-b77b-78789715ef5a | 2024-12-30 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Zydus Lifesciences Limited | a3c0cc1e-1c01-4009-afdc-d35a66546aec | 2024-11-30 | LABETALOL HYDROCHLORIDE | |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 64cd636d-8b48-4f29-b41d-4a048335793e | 2024-11-20 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 5b059ef2-dec0-4cea-b8df-d87df3fea9e2 | 2024-09-06 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.