AZACITIDINE
- Product NDC
- 63759-0003
- 11-digit product format
- 637590003
- Labeler code
- 63759
- Product ID
- 63759-0003_aa9df125-bf25-4ac9-a339-a0e6638be29c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azacitidine for
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Shilpa Medicare Limited
- Application
- ANDA207518
- Marketing category
- ANDA
- Marketing start
- 2016-12-05
- Marketing end
- 0000-00-00
- Substance
- AZACITIDINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207518-001 | AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207518-001 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A207518-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-09-29 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207518-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207518-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207518-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207518-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207518-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207518-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207518-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207518-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207518-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207518-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207518-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207518-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207518-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207518-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207518-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207518-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207518-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207518-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207518-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207518-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207518-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207518-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207518-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207518-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207518-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207518-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207518-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207518-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207518-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207518-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207518-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207518-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207518-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207518-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207518-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207518-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207518-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207518-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A207518-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A207518-001 | AP | 1 | e64feba35796… |
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 | Armas Pharmaceuticals Inc. | 5c0a2d5f-8c34-4c04-8425-7543965cedd4 | 2025-08-05 | Warnings, Adverse reactions | 207518 ANDA207518 |
| Azacitidine | AZACITIDINE | Fresenius Kabi USA, LLC | 3b594aba-e798-4105-b801-0b0d970747c1 | 2025-06-18 | Warnings, Adverse reactions | 207518 ANDA207518 |
| AZACITIDINE | AZACITIDINE FOR | Pilnova Pharma Inc | 0095c67b-42f3-47e6-92db-f77843727bca | 2024-12-16 | Warnings, Adverse reactions | 207518 ANDA207518 |
| AZACITIDINE AZACITIDINE | AZACITIDINE | Dr. Reddy's Laboratories Inc. | d38a1247-28c8-a911-e691-a983a2f9a6e3 | 2017-07-20 | Warnings, Adverse reactions | 207518 ANDA207518 |