Home NDC 0781-3253 Azacitidine
Product NDC 0781-3253
11-digit product format 007813253
Labeler code 0781
Product ID 0781-3253_84226739-5b8c-4e28-a17e-793af710a06f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azacitidine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Sandoz Inc
Application NDA050794
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-09-16
Marketing end 2025-02-28
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-3253-94 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-3253-94 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-3253-94 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-3253-94 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-3253-94 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-3253-94 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050794-001 VIDAZA AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050794-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N050794-001 ODE-399 2029-05-20
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050794-001 VIDAZA 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP RLD, RS 2004-05-19 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZACITIDINE ACTIVE INGREDIENT M801H13NRU AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 12 AZACITIDINE ACTIVE MOIETY M801H13NRU AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 12
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIDAZA AZACITIDINE Celgene Corporation 3495a71a-cc04-4776-851f-f185956f32af 2024-01-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 050794 application number: NDA050794
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-3253-94 00781325394 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3253-94) 2013-09-16 0000-00-00 No No Current