Home NDC 50742-430 DECITABINE
Product NDC 50742-430
11-digit product format 507420430
Labeler code 50742
Product ID 50742-430_c71b018e-22c6-4c0f-a8e8-6e320822e092
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name decitabine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA210984
Marketing category ANDA
Marketing start 2019-09-25
Marketing end 0000-00-00
Substance DECITABINE
Active strength 50 mg/1
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 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 A210984-001 DECITABINE DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS 2019-09-16
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 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 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS 2019-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-09-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210984-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS 2019-09-16 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-430 DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INGENUS PHARMACEUTICALS, LLC] 11 Legacy NDC 20241115_b3a26585-e247-4b2e-a4ce-817b3aac2ff3.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 50742-430-01 50742043001 1 VIAL in 1 CARTON (50742-430-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2019-09-25 0000-00-00 No No Current