Home NDC 68083-173 Deferoxamine mesylate
Product NDC 68083-173
11-digit product format 680830173
Labeler code 68083
Product ID 68083-173_316b7751-fbd4-4b19-b7b7-701554fd3b21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deferoxamine mesylate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA207384
Marketing category ANDA
Marketing start 2017-10-09
Substance DEFEROXAMINE MESYLATE
Active strength 2 g/1
Pharmacologic classes Iron Chelating Activity [MoA], Iron Chelator [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207384-001 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 A207384-002 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207384-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2017-09-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207384-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2017-09-29 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Deferoxamine mesylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFEROXAMINE MESYLATE 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9TKO7EO6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731345 Internal RxNorm lookup 1731350 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 68083-173-01 Deferoxamine mesylate 4 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-173 DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 1 package rows 20240608_598fba68-f46e-4b6e-894c-63c2940b2063.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 · 2 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 68083-173-01 68083017301 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68083-173-01) 2017-10-09 0000-00-00 No No Current