Home NDC 0024-2794 Ferrlecit
Product NDC 0024-2794
11-digit product format 000242794
Labeler code 0024
Product ID 0024-2794_df1cd4cc-f035-435c-a17e-381071f0d9e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium ferric gluconate complex
Dosage form INJECTION
Route INTRAVENOUS
Labeler sanofi-aventis U.S. LLC
Application NDA020955
Marketing category NDA
Marketing start 2014-07-07
Substance SODIUM FERRIC GLUCONATE COMPLEX
Active strength 12.5 mg/mL
Pharmacologic classes Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 1 .
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 N020955-001 FERRLECIT SODIUM FERRIC GLUCONATE COMPLEX EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020955-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020955-001 FERRLECIT 62.5MG/5ML INJECTABLE / INJECTION AB RLD, RS 1999-02-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020955-001 FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) INJECTABLE / INJECTION AB RLD, RS 1999-02-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ferrlecit
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CC9149U2QX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242761 Internal RxNorm lookup 261123 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 0024-2794-01 Ferrlecit 5 mL in 1 VIAL, SINGLE-USE INJECTION 5 12 0024-2794-10 Ferrlecit 10 in 1 CARTON INJECTION 10 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-2794 FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC] 10 Current NDC, Legacy NDC, 2 package rows 20220330_b25b34ab-9cf1-4a2b-bdf2-5eaf66625999.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 Units Marketing start Marketing end Sample Exclude flag Status 0024-2794-01 00024279401 5 mL in 1 VIAL, SINGLE-USE 5 ml Historical 0024-2794-10 00024279410 10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) 2014-07-07 0000-00-00 No No Current