Application 019130
- Type
- NDA
- Sponsor
- MCGAW
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | No | No |
| 002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/100ML | No | No |
| 003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | ||
| N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | ||
| N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019130-002 | HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 1,000 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019130-003 | HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019130-001 | HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | 200 UNITS/100ML | INJECTABLE / INJECTION | 1984-12-31 | 1e350fbaab3a… |
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 | 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 | Hospira, Inc. | c8c4edd2-ee9e-4558-6b8c-b83adc242a0a | 2026-04-29 | 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 | REMEDYREPACK INC. | a5fab0b1-c472-489c-ba87-2f8e53356173 | 2026-01-16 | 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 |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceuticals | 6d5eae7d-a5f6-411c-b589-3e5f7eecc875 | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |