Home NDC 69097-905 Decitabine
Product NDC 69097-905
11-digit product format 690970905
Labeler code 69097
Product ID 69097-905_b1c56b73-f0bc-403f-85a2-c73de0c43bc5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Decitabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Cipla USA Inc.
Application ANDA205539
Marketing category ANDA
Marketing start 2021-09-17
Marketing end 0000-00-00
Substance DECITABINE
Active strength 50 mg/10mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 4 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 69097-905-67 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 69097-905-67 f5e01cc5f278…a2eaf40c39c3…
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 A205539-001 DECITABINE DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205539-001 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 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 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205539-001 DECITABINE 50MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-11-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 Marketing start Marketing end Sample Exclude flag Status 69097-905-67 69097090567 1 VIAL, SINGLE-USE in 1 CARTON (69097-905-67) > 10 mL in 1 VIAL, SINGLE-USE 2021-09-17 0000-00-00 No No Current