Application 019042
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | No | No |
| 002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | No | No |
| 004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | ||
| N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | ||
| N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1985-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019042-002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019042-004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019042-001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1985-03-29 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceticals | ef309d83-7262-4874-8580-f4ca254f963a | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceuticals | 6d5eae7d-a5f6-411c-b589-3e5f7eecc875 | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceuticals | feec2820-502f-4a97-84c9-f173729c51d3 | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceuticals | 8ebe4b4d-cb28-47e8-9598-6105d250b3d2 | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Henry Schein, Inc. | 3a998729-c912-4e21-8e49-d1e72ba6fe9e | 2025-10-31 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Pfizer Laboratories Div Pfizer Inc | 56dc3074-f1c5-45a3-b923-f1d14858e06d | 2025-10-03 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Meitheal Pharmaceuticals Inc. | 02fb700d-a28c-4d45-b78d-382dc0d5986c | 2025-09-26 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Medical Purchasing Solutions, LLC | 3edf9198-b88d-7808-e063-6394a90ae89c | 2025-09-15 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Medical Purchasing Solutions, LLC. | 3ea2bd53-ed13-a516-e063-6394a90a5dd9 | 2025-09-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 9207cef5-4cec-41e7-a351-29ba726feb44 | 2025-08-15 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 07438e10-1589-4683-9f26-e5494d076cf0 | 2025-08-15 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hikma Pharmaceuticals USA Inc. | 7014808d-cec9-4b2c-8eb5-940493e356ab | 2025-08-13 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Civica, Inc. | 1e362730-5a56-4948-a90f-2cb75fed9e91 | 2025-07-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | NorthStar RxLLC | 34b8fe93-ee34-4a35-9af5-5d41705a28e9 | 2025-05-29 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | NorthStar RxLLC | c4fa6d34-e76b-4c3c-b74d-21ce41432a04 | 2025-05-29 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | NorthStar RxLLC | 41dd053d-49f6-4eb1-b9e7-3508ede82df8 | 2025-05-29 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | a07195bc-7442-32b4-e053-2995a90a0151 | 2025-05-07 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Meitheal Pharmaceuticals Inc. | 83a59e7d-63e9-4eb8-87f0-52039d6893a5 | 2025-03-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hepalink USA Inc. | c4c6bc1f-e0c7-fd0d-e053-2995a90abdef | 2025-02-19 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Northstar Rx LLC | 2edf6d35-5cf3-b7ff-e063-6394a90a4f33 | 2025-02-19 | Warnings, Adverse reactions | HEPARIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.