Home NDC 0409-2337-25 Deferoxamine Mesylate
Product NDC 0409-2337
Requested package NDC 0409-2337-25
11-digit product format 004092337
Labeler code 0409
Product ID 0409-2337_0c19b646-2901-4648-a502-a226b1eb0fef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deferoxamine Mesylate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application ANDA076019
Marketing category ANDA
Marketing start 2005-03-31
Substance DEFEROXAMINE MESYLATE
Active strength 2 g/1
Pharmacologic classes Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076019-001 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 A076019-002 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17
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 · 86 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 2026-09-14 22:38:34 2026-08 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP RS 2004-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076019-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2004-03-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076019-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2004-03-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0409-2337-15 Deferoxamine Mesylate 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 27 0409-2337-25 Deferoxamine Mesylate 4 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 4 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEFEROXAMINE MESYLATE ACTIVE INGREDIENT V9TKO7EO6K DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 11 DEFEROXAMINE MESYLATE ACTIVE INGREDIENT V9TKO7EO6K DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 11 DEFEROXAMINE ACTIVE MOIETY J06Y7MXW4D DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 11 DEFEROXAMINE ACTIVE MOIETY J06Y7MXW4D DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2337 DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 23 Current NDC, Legacy NDC, 2 package rows 20240319_f9ab6b1c-98d0-4373-0e9b-b10cb4a67543.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 0409-2337-25 00409233725 4 VIAL, SINGLE-USE in 1 CARTON (0409-2337-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-2337-15) 2005-03-31 0000-00-00 No No Current