Application 019802
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | No | No |
| 003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | ||
| N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | ||
| N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | ||
| N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 |
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 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1992-07-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019802-001 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019802-002 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019802-003 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019802-005 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | 1992-07-20 | 2680178bc6a6… |
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 | Sandoz Inc. | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 2025-02-19 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Meitheal Pharmaceuticals Inc. | 7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c | 2025-02-04 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Meitheal Pharmaceuticals Inc. | 57f1ec87-8a7d-41da-b8b8-9ecc8601c60f | 2025-01-22 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | McKesson Corporation dba SKY Packaging | 7f05762a-7527-4796-b21e-68277aec379e | 2025-01-21 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | 9bd0f982-30f4-4e38-e053-2a95a90a3e15 | 2025-01-08 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | 9a5549ae-527a-1b83-e053-2a95a90a133d | 2025-01-08 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Meitheal Pharmaceuticals Inc. | ad0f410c-6121-43f9-9844-943472961cb0 | 2025-01-08 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | BE Pharmaceuticals Inc. | 295ea9c6-d08c-40f0-a908-de0fdac44644 | 2024-10-30 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | BE Pharmaceuticals Inc. | 6be171fb-c85f-4336-a88d-b4d97bb0fe03 | 2024-10-30 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Phlow Corporation | cece935c-1c0a-4949-b023-d6df3d53fbfa | 2024-05-16 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 25b0ba06-3274-4a3f-8c39-42d13764ecdf | 2024-04-30 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 2024-04-30 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | 971505d4-f78c-6f5d-e053-2995a90a00e0 | 2024-01-29 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | a120bdfd-21e1-4024-82a7-13cfeed290c1 | 2024-01-05 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM IN SODIUM CHLORIDE | HEPARIN SODIUM | Baxter Healthcare Corporation | 0d929726-76c3-48fc-b4e7-fd06409f9fb3 | 2022-01-03 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 3facd525-b9ad-46d0-b63e-f13a5f6d591d | 2021-09-01 | Warnings, Adverse reactions | HEPARIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.