Application 019952
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 4,000 UNITS/100ML | Yes | Yes |
| 004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | Yes | Yes |
| 005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | |
| N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 |
| N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019952-004 | AP |
| N019952-005 | AP |
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 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019952-004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 5,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019952-005 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 10,000 UNITS/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-07-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019952-001 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 4,000 UNITS/100ML | INJECTABLE / INJECTION | RLD, RS | 1992-07-20 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019952-004 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N019952-005 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N019952-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019952-005 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019952-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019952-005 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019952-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019952-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019952-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019952-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019952-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019952-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019952-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019952-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019952-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019952-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019952-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019952-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019952-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019952-005 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019952-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019952-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019952-004 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019952-005 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019952-004 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019952-005 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019952-004 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019952-005 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019952-004 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019952-005 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019952-004 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019952-005 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019952-004 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019952-005 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019952-004 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019952-005 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019952-004 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019952-005 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019952-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019952-004 | AP | 1 | 4b0b4de00fa7… |
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 | Hospira, Inc. | c8c4edd2-ee9e-4558-6b8c-b83adc242a0a | 2026-08-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Henry Schein, Inc. | 45dc6b8b-ed5d-40a2-8d9c-084c863ae93a | 2026-08-19 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 239b4816-6a55-451b-bf40-e611be07d12f | 2026-08-10 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 9ea0a519-dc7c-42e3-939e-2a7c80eedd25 | 2026-07-10 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | e0cc5f44-9a67-4274-a48a-d6118e96d391 | 2026-06-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 62cfd1bb-894f-4429-b362-1e40981dccc6 | 2026-06-11 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 9cd7abe6-3923-4007-8491-273ef6e05ad7 | 2026-06-02 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | eede8a0c-5ae6-4166-84b3-12081405f08e | 2026-05-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 2026-05-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | 0413f511-6b34-4c15-e48b-3fad08baacbe | 2026-05-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | 32e34077-aff1-4ec7-f9b0-b8e240768fb8 | 2026-05-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | 51197aa6-de34-3a55-e063-6294a90a89c9 | 2026-05-05 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 2026-04-30 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Plano Pharmaceuticals Inc. | 4deaa9ac-91aa-d96b-e063-6294a90a47bd | 2026-03-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | 6c181d7e-aed2-4975-30ac-d39a94cca7ec | 2026-03-24 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Medical Purchasing Solutions, LLC | 4c118b39-cb4e-31a9-e063-6394a90a41b0 | 2026-03-02 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Medical Purchasing Solutions, LLC | 463e0624-b8c3-386b-e063-6294a90afd28 | 2025-12-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 2025-11-28 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | ed937dd2-8fab-4875-a1e8-627b71ccb7fb | 2025-11-27 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceticals | ef309d83-7262-4874-8580-f4ca254f963a | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-9567 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9567 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9567 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9577 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9577 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9577 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9587 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9587 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-9587 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | B. Braun Medical Inc. | NDA | Current |
| 50090-4537 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | A-S Medication Solutions | NDA | Current |
| 50090-4537 | Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74754 | SUPPL | 2023-07-13 |
| 74746 | SUPPL | 2023-07-13 |
| 56426 | SUPPL | 2018-11-13 |
| 12096 | SUPPL | 2016-06-01 |
| 19885 | SUPPL | 2016-05-27 |
| 34138 | SUPPL | 2013-09-09 |
| 19884 | SUPPL | 2013-09-04 |
| 34137 | SUPPL | 2013-01-11 |
| 1849 | SUPPL | 2013-01-11 |
| 19883 | SUPPL | 2011-12-29 |
| 34136 | SUPPL | 2011-12-23 |
| 34135 | SUPPL | 2009-03-17 |
| 1848 | SUPPL | 2004-04-20 |