NDC 70121-1644-01 - Decitabine
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
- 70121-1644
- Requested NDC
- 70121-1644-01
- Package NDCs from labels
- 70121-1644-1, 70121-1644-01
- Manufacturer
- Amneal Pharmaceuticals LLC | Chemi SpA | Chemi Pharma Ltd.
- Effective date
- 2021-02-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Decitabine - Amneal Pharmaceuticals LLC | Chemi SpA | Chemi Pharma Ltd. | Amneal Pharmaceuticals LLC | Chemi SpA | Chemi Pharma Ltd. | 2021-02-12 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70121-1644-1 | Decitabine | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | 4 | |
| 70121-1644-1 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70121-1644 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210220_40e7ef72-8df5-4adf-a269-4ae1c26eb6f9.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-1644-1 | EA - Each | 70121-1644 | e17471bf-9b06-41e1-932b-3cb9c78a1aad | 1 | 2020-02-13 |
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 |
|---|---|---|---|---|---|---|
| Potassium Phosphates | POTASSIUM PHOSPHATES | Fresenius Kabi USA, LLC | 357c3020-ea6f-4401-a2e7-cebb82b03144 | 2025-04-15 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Potassium Phosphates | POTASSIUM PHOSPHATES | Cipla USA Inc. | f1f26a17-d2e2-48f5-9054-8ee7e380556e | 2025-02-28 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Potassium Phosphates | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC | Fresenius Kabi USA, LLC | 475f5cd7-45bd-412a-b419-9962585d6cda | 2025-02-28 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 89136c51-a60b-4269-bd05-9489f060a734 | 2024-12-31 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| decitabine | DECITABINE | Hikma Pharmaceuticals USA Inc. | 8c5d6067-16a1-43ab-9e52-a33c600a5c44 | 2024-12-26 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Potassium Phosphate | POTASSIUM PHOSPHATE | Somerset Therapeutics, LLC | 52f07402-1869-4a97-9c92-9729dc611f85 | 2024-07-11 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Decitabine | DECITABINE | Accord Healthcare Inc. | b46df7d7-d98e-4c7e-b1ee-e03e258781c4 | 2024-07-09 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Decitabine | DECITABINE | Camber Pharmaceuticals, Inc. | 5662c353-05d0-4bd8-87e4-c92ec9ca861e | 2024-06-26 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Isolyte S pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE | B. Braun Medical Inc. | 150437b6-320e-4c69-a434-2a26a1f0b2e4 | 2023-10-06 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Decitabine | DECITABINE | Eugia US LLC | a99f92cf-88f9-469b-aa69-44831e0bd4ab | 2023-07-29 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| K-Phos No. 2 | POTASSIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | Beach Products, Inc. | 9f446400-c403-4971-879e-1341f7f7d9da | 2023-02-23 | Adverse reactions | 4J9FJ0HL51 |
| K Phos Original | POTASSIUM PHOSPHATE, MONOBASIC | Beach Products, Inc. | 04557ab3-6d21-49b4-b849-744c75b8a630 | 2023-02-23 | Adverse reactions | 4J9FJ0HL51 |
| K Phos Neutral | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | Beach Products, Inc. | 83376725-ee0f-40ad-bd90-31a61b9445cf | 2023-02-23 | Adverse reactions | 4J9FJ0HL51 |
| DECITABINE | DECITABINE | Nivagen Pharmaceuticals, Inc. | 150537a8-10ac-422d-bf33-68b1a408e566 | 2022-02-28 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Decitabine | DECITABINE | Qilu Pharmaceutical Co., Ltd. | 5b2dce6f-c715-47dc-971e-06244ccd7548 | 2021-10-18 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| decitabine | DECITABINE | Gland Pharma Limited | 39a26b24-e9d4-4974-9788-d025c51fc94f | 2021-09-15 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| FERRUM PHOSPHORICUM 6X | HYDRATED IRON III PHOSPHATE | Seroyal USA | 14f4f926-0742-12cd-e054-00144ff8d46c | 2021-07-14 | Warnings | 4J9FJ0HL51 |
| Decitabine | DECITABINE | Amneal Pharmaceuticals LLC | 40e7ef72-8df5-4adf-a269-4ae1c26eb6f9 | 2021-02-12 | Warnings, Adverse reactions | ANDA206033 70121-1644-1 70121-1644 70121164401 636631 5b9c6cb1-3315-4023-8a3b-9c92596d01f9 40e7ef72-8df5-4adf-a269-4ae1c26eb6f9 776B62CQ27 |
| Decitabine | DECITABINE | Novadoz Pharmaceuticals LLC | a1b43089-bc88-4ac6-bdee-9cc38ec30f4e | 2021-01-01 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Decitabine | DECITABINE | Northstar Rx LLC | 1abbe952-58bc-4dbc-b06a-fb79167bcd66 | 2020-08-17 | Warnings, Adverse reactions | 636631 776B62CQ27 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.