NDC 67184-0535-01 - 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
- 67184-0535
- Requested NDC
- 67184-0535-01
- Package NDCs from labels
- 67184-0535-1, 67184-0535-01
- Manufacturer
- Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.
- Effective date
- 2021-10-18
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Decitabine | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd. | 2021-10-18 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67184-0535-1 | Decitabine | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | 2 | |
| 67184-0535-1 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67184-0535 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20211020_5b2dce6f-c715-47dc-971e-06244ccd7548.zip |
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 |
|---|---|---|---|---|---|---|
| Acidum Muriaticum | ACIDUM MURIATICUM | Hahnemann Laboratories, INC. | f2aad04c-5151-6cab-e053-2a95a90ad3a7 | 2023-01-19 | QTT17582CB | |
| DECITABINE | DECITABINE | Nivagen Pharmaceuticals, Inc. | 150537a8-10ac-422d-bf33-68b1a408e566 | 2022-02-28 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| BHI Hemorrhoid | HORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFUR | MediNatura Inc | d7df7d3e-48ad-4f58-aef5-a7bd48d2f191 | 2022-01-05 | Warnings | QTT17582CB |
| Joette Calabrese Survivalist Kit | ABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIP | OHM PHARMA INC. | 1ac2a2c4-704e-4efa-aa44-acc71d300f70 | 2021-12-29 | Warnings | QTT17582CB |
| Decitabine | DECITABINE | Qilu Pharmaceutical Co., Ltd. | 5b2dce6f-c715-47dc-971e-06244ccd7548 | 2021-10-18 | Warnings, Adverse reactions | ANDA212826 67184-0535-1 67184-0535 67184053501 636631 0afb3dc7-6072-4a53-acc4-59589fb8491e 5b2dce6f-c715-47dc-971e-06244ccd7548 776B62CQ27 |
| decitabine | DECITABINE | Gland Pharma Limited | 39a26b24-e9d4-4974-9788-d025c51fc94f | 2021-09-15 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Fungisode | ARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHUR | Seroyal USA | 55c5dfc4-3757-6ac2-e054-00144ff88e88 | 2021-07-22 | Warnings | QTT17582CB |
| 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 | 636631 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 |
| Decitabine | DECITABINE | Novadoz Pharmaceuticals LLC | ae6c4580-3a3a-4c42-903a-1565d79521f8 | 2020-08-01 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| Decitabine | DECITABINE | Mylan Institutional LLC | 447a9fbd-106d-4ff6-8fd0-bb38a8c90e17 | 2020-07-26 | Warnings, Adverse reactions | 636631 776B62CQ27 |
| decitabine | DECITABINE | Sun Pharmaceutical Industries, Inc. | c155d6ba-9a16-406c-919e-65a149689ab9 | 2020-07-23 | Warnings, Adverse reactions | 636631 |
| Dextrose and Electrolyte No. 48 | SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | b283a454-0c20-4fbf-92d3-dae1f3cd3cad | 2020-02-13 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| TIS-U-SOL | SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE | Baxter Healthcare Corporation | 9da4121f-d62d-4da4-8dfb-0494da16015f | 2014-02-21 | 4J9FJ0HL51 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.