Home NDC 43598-143-62 Azacitidine
Product NDC 43598-143
Requested package NDC 43598-143-62
11-digit product format 435980143
Labeler code 43598
Product ID 43598-143_bf6007cd-07b7-df87-f778-610cad2941ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azacitidine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA207234
Marketing category ANDA
Marketing start 2022-04-20
Marketing end 0000-00-00
Substance AZACITIDINE
Active strength 100 mg/50mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43598-143 43598-143-62 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43598-143 43598-143-62 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43598-143 43598-143-62 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A207234-001 AZACITIDINE AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207234-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207234-001 AZACITIDINE 100MG/VIAL POWDER / INTRAVENOUS, SUBCUTANEOUS AP 2017-06-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-143 AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.] 4 Legacy NDC 20250119_314faacb-45e7-332e-acc7-b9ff5a475b0c.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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-143-62 43598014362 1 mL in 1 CARTON (43598-143-62) 1 ml 2022-04-20 0000-00-00 No No Current