NDC 68001-391-80 - Mitomycin
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
- 68001-391
- Requested NDC
- 68001-391-80
- Package NDCs from labels
- 68001-391-80, 68001-391-79
- Manufacturer
- BluePoint Laboratories | Accord Healthcare Inc | Intas Pharmaceuticals Ltd | Intas Pharmaceuticals Limited
- Effective date
- 2021-06-09
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| MITOMYCIN FOR INJECTION USP, 5 mg/vial, 20 mg/vial and 40 mg/vial | BluePoint Laboratories | Accord Healthcare Inc | Intas Pharmaceuticals Ltd | Intas Pharmaceuticals Limited | 2021-06-09 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-391-79 | Mitomycin | 1 in 1 BOX, UNIT-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | 2 | |
| 68001-391-80 | Mitomycin | 80 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 80 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-391-79 | EA - Each | 68001-391 | 7227da6c-347c-4def-ac20-f171c165771e | 1 | 2019-06-19 |
| 68001-391-80 | EA - Each | 68001-391 | 649c9e29-7d20-4979-9fb9-1ae3e2dbe111 | 1 | 2019-06-19 |
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 |
|---|---|---|---|---|---|---|
| Mitomycin | MITOMYCIN | Hikma Pharmaceuticals USA Inc. | 5917f7a7-cd20-407b-8dda-9fd58c5f47a6 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 1740898 1740900 50SG953SK6 |
| 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 |
| Mitomycin | MITOMYCIN | Bryant Ranch Prepack | 5f41676f-f687-47db-871c-35bbf2447a98 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 1740894 50SG953SK6 |
| 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 |
| 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 |
| Mitomycin | MITOMYCIN | Accord Healthcare, Inc. | ff676355-313d-4575-8f2f-e4a1e9527477 | 2025-04-22 | Boxed warning, Warnings, Adverse reactions | ANDA064144 1740898 1740894 1740900 50SG953SK6 |
| MUTAMYCIN | MITOMYCIN | Accord BioPharma Inc. | cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | ANDA064144 1740898 1740894 1740900 50SG953SK6 |
| Mitomycin | MITOMYCIN | Bryant Ranch Prepack | 799a06b1-7697-42a3-b31a-c9d621b34f6f | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 1740894 50SG953SK6 |
| MITOMYCIN | MITOMYCIN | BluePoint Laboratories | 57129df7-d6b1-419e-90ec-54f9b5182e7c | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 1740898 1740894 1740900 50SG953SK6 |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| MITOMYCIN | MITOMYCIN | Eugia US LLC | f5a010cf-5954-4e6d-acfa-fb414efdf471 | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | 1740898 1740894 1740900 50SG953SK6 |
| Mitomycin | MITOMYCIN | Archis Pharma LLC | cef5026c-8bc3-4428-a178-6effff4dcb3f | 2023-09-21 | Boxed warning, Warnings, Adverse reactions | 1740894 50SG953SK6 |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Mitomycin | MITOMYCIN | Archis Pharma LLC | 2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f | 2023-06-05 | Boxed warning, Warnings, Adverse reactions | 1740898 1740894 1740900 50SG953SK6 |
| Mitomycin | MITOMYCIN | Sagent Pharmaceuticals | 10c41a58-c305-4240-80d2-caa070412648 | 2023-05-24 | Boxed warning, Warnings, Adverse reactions | 1740894 1740900 50SG953SK6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.