NDC 70121-1237-01 - AZACITIDINE
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
- 70121-1237
- Requested NDC
- 70121-1237-01
- Package NDCs from labels
- 70121-1237-1, 70121-1237-01
- Manufacturer
- Amneal Pharmaceuticals LLC
- Effective date
- 2024-08-20
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| AZACITIDINE - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals LLC | 2024-08-20 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70121-1237-1 | AZACITIDINE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70121-1237 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240922_80a43736-0598-4e4b-85ba-e29daa290c8f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-1237-1 | EA - Each | 70121-1237 | 9c6d024e-2839-4022-b7fa-91202485bc1d | 1 | 2023-02-06 |
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 |
|---|---|---|---|---|---|---|
| AZACITIDINE | AZACITIDINE FOR | Pilnova Pharma Inc | 0095c67b-42f3-47e6-92db-f77843727bca | 2024-12-16 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | Accord Healthcare Inc. | 70140e11-33f1-2240-e053-2991aa0a0480 | 2024-12-03 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | Dr. Reddy's Laboratories Inc. | 060d56e7-1a24-87c1-7f40-149ecf424f7c | 2024-10-30 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | Sandoz Inc | 7f89fcbd-d3f4-4112-8733-69baea41255e | 2024-10-24 | Warnings, Adverse reactions | 485246 M801H13NRU |
| AZACITIDINE | AZACITIDINE | Amneal Pharmaceuticals LLC | 80a43736-0598-4e4b-85ba-e29daa290c8f | 2024-08-20 | Warnings, Adverse reactions | ANDA211549 70121-1237-1 70121-1237 70121123701 485246 38a5005c-7a0b-48c6-bba5-a996ccf1c847 80a43736-0598-4e4b-85ba-e29daa290c8f M801H13NRU |
| Azacitidine | AZACITIDINE | Dr. Reddy's Laboratories Inc. | 71d8d758-86c9-b571-aed1-719654fd4b82 | 2024-07-31 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | Dr. Reddy's Laboratories Inc. | 33397835-15a9-d89f-bd75-8b915f5c4dbf | 2024-07-31 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | NorthStar RxLLC | 81366ec1-9689-4857-ded6-3d6342fe5132 | 2024-07-31 | Warnings, Adverse reactions | 485246 M801H13NRU |
| AZACITIDINE | AZACITIDINE | Eugia US LLC | ecd108bd-bb5f-4b2e-ad91-210fca452e9b | 2024-07-23 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | MSN LABORATORIES PRIVATE LIMITED | d24f1fc5-17c6-4e0c-b852-72692e835cff | 2024-07-04 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Azacitidine | AZACITIDINE | Hikma Pharmaceuticals USA Inc. | ff73515d-bd55-4eb5-992b-d2138c80887e | 2024-04-11 | Warnings, Adverse reactions | 485246 M801H13NRU |
| VIDAZA | AZACITIDINE | Celgene Corporation | 3495a71a-cc04-4776-851f-f185956f32af | 2024-01-29 | Warnings, Adverse reactions | 485246 M801H13NRU |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Azacitidine | AZACITIDINE | BluePoint Laboratories | 7f9f1563-f8b2-4e83-a4ec-af41fed0e627 | 2023-04-21 | Warnings, Adverse reactions | 485246 M801H13NRU |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
| Azacitidine | AZACITIDINE | Panacea Biotec Limited | 9abb489d-ce54-4140-83f6-b756f00b0967 | 2020-10-05 | Warnings, Adverse reactions | 485246 M801H13NRU |
| AZACITIDINE AZACITIDINE | AZACITIDINE | Dr. Reddy's Laboratories Inc. | d38a1247-28c8-a911-e691-a983a2f9a6e3 | 2017-07-20 | Warnings, Adverse reactions | 485246 M801H13NRU |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.