NDC 0781-3158-94 - bivalirudin
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0781-3158
- Requested NDC
- 0781-3158-94
- Package NDCs from labels
- 0781-3158-94, 0781-3158-95
- Manufacturer
- Sandoz Inc | Novetide Ltd.
- Effective date
- 2019-09-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| bivalirudin - Sandoz Inc | Novetide Ltd. | Sandoz Inc | Novetide Ltd. | 2019-09-30 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-3158-94 | bivalirudin | 1 in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1 | 4 | |
| 0781-3158-95 | bivalirudin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-3158-94 | EA - Each | 0781-3158 | d028d52b-d61b-4c8e-9fab-17b50274cf97 | 1 | 2015-08-04 |
| 0781-3158-95 | EA - Each | 0781-3158 | 528c27e3-6b76-4343-97f5-3f2974930f2f | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BIVALIRUDIN | ACTIVE INGREDIENT | TN9BEX005G | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
| BIVALIRUDIN | ACTIVE MOIETY | TN9BEX005G | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 |
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 |
|---|---|---|---|---|---|---|
| Bivalirudin | BIVALIRUDIN | Avenacy, LLC | 42aa2630-83d6-433d-8277-0f672cf8d71d | 2026-08-20 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| BIVALIRUDIN | BIVALIRUDIN | Eugia US LLC | e574d04f-67b4-4a84-9d66-8c2d54f95120 | 2026-07-10 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 3OWL53L36A |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | 3OWL53L36A |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | 3OWL53L36A |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | 3OWL53L36A |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| bivalirudin | BIVALIRUDIN | Civica, Inc. | 19a4afc5-151d-4d3c-bfef-48aa8797d695 | 2025-09-10 | Warnings, Adverse reactions | NDA020873 308769 TN9BEX005G |
| Bivalirudin | BIVALIRUDIN | Fresenius Kabi USA, LLC | 50975be1-6d1f-497c-b989-1825a0fae1a7 | 2025-08-27 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| Bivalirudin | BIVALIRUDIN | Fresenius Kabi USA, LLC | af943fa0-ab0f-4b62-9ff0-54ee24cdb772 | 2025-05-08 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Bivalirudin | BIVALIRUDIN | Mylan Institutional LLC | 95d150e7-f152-4091-b831-e469c9578a54 | 2025-03-24 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Bivalirudin | BIVALIRUDIN | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 61de12ff-e280-4bab-9804-43869ec45fa7 | 2024-12-23 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Bivalirudin | BIVALIRUDIN | Accord Healthcare, Inc. | c20969cb-72d4-469b-9bd8-332250d896c3 | 2024-08-15 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Bivalirudin | BIVALIRUDIN | MAIA Pharmaceuticals, Inc. | c727199d-f4cd-4658-8fdf-568590beface | 2024-05-27 | Warnings, Adverse reactions | TN9BEX005G |
| BIVALIRUDIN | BIVALIRUDIN | Meitheal Pharmaceuticals Inc. | 26fb46f6-0088-42b8-b6f2-c67224776803 | 2024-04-04 | Warnings, Adverse reactions | 308769 TN9BEX005G |
| Bivalirudin | BIVALIRUDIN | Par Health USA, LLC | 91cf9d00-29e0-4357-a184-f70026c47edb | 2024-03-01 | Warnings, Adverse reactions | TN9BEX005G |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.