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| LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| LABETALOL HYDROCHLORIDE | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| NORMODYNE | LABETALOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-08-31 | |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| NORMODYNE | LABETALOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | |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| NORMODYNE | LABETALOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 | |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| NORMODYNE | LABETALOL HYDROCHLORIDE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-08-01 |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 | Bryant Ranch Prepack | 94abdd54-a8e2-4858-8183-6c5d04dbceb5 | 2024-08-20 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 1fce27dd-90a6-45cf-9bd7-13147d3cc0d7 | 2024-08-12 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 706a877b-c388-43e7-b083-518111b288b0 | 2024-08-06 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 30f9fdef-8781-4327-9a8d-812cb31ff041 | 2024-07-10 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 30280d40-28df-4c88-93bd-357a7c528906 | 2024-06-21 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 5a39bb96-4a60-49e8-859c-16bda0fe18e4 | 2024-06-05 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Gland Pharma Limited | 48caf986-3126-48e1-afcd-16d65c9cfe00 | 2024-05-21 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Fosun Pharma USA Inc. | 4a5ffab2-a3b8-411e-992d-7f38d508643a | 2024-05-16 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | a007d945-417c-4647-ab03-95ca219d7d38 | 2024-05-01 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 143ae21e-c350-4c92-b318-7537f4e46596 | 2024-04-08 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 83a6e770-207a-46bc-992d-c1ad90d1006d | 2023-10-30 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 1a71964e-e6fa-443e-bfdd-f8852f8cf29e | 2023-10-26 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | c586ab65-56e8-4a4f-b471-902198d3e58c | 2023-10-17 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | NorthStar Rx LLC | a2d07ec0-3718-40eb-9d0a-79c557c486b9 | 2023-04-28 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Cadila Pharmaceuticals Limited | 5fba93fc-4580-48c2-a1ec-5d446680adcf | 2022-12-09 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol hydrochloride | LABETALOL HYDROCHLORIDE | Proficient Rx LP | c0301841-e209-4242-bace-58a20e6dd01b | 2022-11-01 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| labetalol hydrochloride | LABETALOL HYDROCHLORIDE | Sagent Pharmaceuticals | da8af6c2-d822-4ae5-9c2d-a1d161bdefd0 | 2022-04-12 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Epic Pharma, LLC | b950655d-a9f8-4ace-bb56-0c7abbca231e | 2021-09-30 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Hospira, Inc. | d3579d45-a964-40fe-e3a2-a3a997c8b7b9 | 2021-05-28 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Fosun Pharma USA Inc. | f18dff28-f6f5-4ecb-9797-25062e247559 | 2021-01-28 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.