Home NDC 68083-528 decitabine
Product NDC 68083-528
11-digit product format 680830528
Labeler code 68083
Product ID 68083-528_39a26b24-e9d4-4974-9788-d025c51fc94f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name decitabine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA205539
Marketing category ANDA
Marketing start 2020-11-23
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 2026-12-31
Current FDA listing Yes 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# Additional Listing Data#
Finished product Yes
Brand name base decitabine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DECITABINE 50 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 776B62CQ27 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636631 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-528-01 decitabine 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 68083-528-01 decitabine 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-528 DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 1 Current NDC, Legacy NDC, 2 package rows 20210917_39a26b24-e9d4-4974-9788-d025c51fc94f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68083-528-01 68083052801 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2020-11-23 0000-00-00 No No Current