Application 018686
- Type
- NDA
- Sponsor
- SCHERING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORMODYNE | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018686-001 | NORMODYNE | LABETALOL HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 |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| 2026-08 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | RLD | 1984-08-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | RLD | 1984-08-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | 1984-08-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | RLD | 1984-08-01 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | RLD | 1984-08-01 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | RLD | 1984-08-01 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | RLD | 1984-08-01 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | 1984-08-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | 1984-08-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018686-001 | NORMODYNE | 5MG/ML | INJECTABLE / INJECTION | 1984-08-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018686-001 | NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-08-01 | f41ea6bd6efb… |
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 | REMEDYREPACK INC. | ae5d7b3b-e444-48d3-9d85-9b07319f9374 | 2026-04-10 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Advagen Pharma Ltd | 106a0959-5830-489f-ba60-afd4eb0fac36 | 2026-04-02 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Advagen Pharma Ltd | 1c680447-b43a-4ff1-bc64-2c2174ca1c9a | 2026-04-02 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | d4364caf-46c6-4144-9ba5-2c561e4f3a95 | 2026-03-26 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 3909ac9e-6818-4c5d-ad0e-52865a574b45 | 2026-03-25 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 35e7bce0-d9ff-4f8b-95c5-218da2a2d929 | 2026-03-25 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | f7f7fade-98a6-4741-bfb9-f1eb54ad4565 | 2026-03-25 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | d207396a-068e-4229-88cc-a1a4df7aeff2 | 2026-03-07 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | b4a5f170-a400-4986-8c64-f55d0413f0f6 | 2026-03-07 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | bf84ebae-3c91-4448-b1db-8e5ed3053866 | 2026-03-05 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Major Pharmaceuticals | 35b5fd32-581d-427b-9a13-b7a02846d21d | 2026-03-03 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Civica, Inc. | d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8 | 2026-03-03 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8 | 2026-03-02 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | ed0188ba-3fd3-4680-a829-ba242a115fab | 2026-02-25 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Biocon Pharma Inc. | 27e4ab03-c17b-4268-912c-e45a5e8f8dd8 | 2026-02-19 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 0db22a64-1863-4188-850b-273ea746e327 | 2026-02-09 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | d8b69cc9-bdee-4e24-a3d8-d1887de5a17d | 2026-02-06 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 6f919513-500e-4a05-935e-b6fc1615368a | 2026-01-29 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Northwind Health Company, LLC | faf7a1ff-f18a-8ca7-e053-6394a90a1b1f | 2026-01-01 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Innogenix, Inc. | 82fc2d64-0572-4a9b-94fc-f6eb8d930c54 | 2025-12-23 | Warnings, Adverse reactions | LABETALOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.