Sodium Ferric Gluconate Complex in Sucrose

Product NDC
0143-9298
11-digit product format
001439298
Labeler code
0143
Product ID
0143-9298_4272216c-1e53-4180-a731-0592e772666f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Ferric Gluconate Complex in Sucrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078215
Marketing category
ANDA
Marketing start
2011-03-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSESODIUM FERRIC GLUCONATE COMPLEXEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078215-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-313f01610625f2…
2019-09-15 20:21 UTC2019-09A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE62.5MG/5MLINJECTABLE / INJECTIONAB2011-03-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078215-001SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)INJECTABLE / INJECTIONAB2011-03-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078215-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078215-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078215-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078215-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078215-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078215-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078215-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078215-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078215-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078215-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078215-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078215-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078215-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078215-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078215-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078215-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078215-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078215-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078215-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078215-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078215-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078215-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078215-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078215-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078215-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078215-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078215-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078215-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078215-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078215-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078215-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078215-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078215-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078215-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078215-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078215-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078215-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078215-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078215-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078215-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Ferric Gluconate Complex in Sucrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FERRIC GLUCONATE COMPLEX12.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CC9149U2QXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242761Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
36377351-d208-4363-8826-0acfea3f0cc1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9298-01Sodium Ferric Gluconate Complex in Sucrose5 mL in 1 VIAL, SINGLE-DOSEINJECTION55
0143-9298-10Sodium Ferric Gluconate Complex in Sucrose10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9298-01ML - Milliliter0143-9298a5376a93-9178-4b2c-a4b0-4269ce8254d912018-03-08
0143-9298-10ML - Milliliter0143-92985bbd4413-8e38-450b-9ec5-26cdd708d47012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9298SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20230609_36377351-d208-4363-8826-0acfea3f0cc1.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Ferric Gluconate Complex in SucroseSODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEHikma Pharmaceuticals USA Inc.218d1b8d-b24f-4f77-b588-97c7dd1c2eec2025-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078215
application number: ANDA078215
Sodium Ferric Gluconate Complex in SucroseSODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEHikma Pharmaceuticals USA Inc.36377351-d208-4363-8826-0acfea3f0cc12022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078215
application number: ANDA078215
ndc (product): 0143-9298

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242761sodium ferric gluconate complex (as iron) 62.5 MG in 5 mL InjectionPSN36377351-d208-4363-8826-0acfea3f0cc15
2427615 ML sodium ferric gluconate complex 12.5 MG/ML InjectionSCD36377351-d208-4363-8826-0acfea3f0cc15
242761sodium ferric gluconate complex (as elemental iron) 62.5 MG per 5 ML InjectionSY36377351-d208-4363-8826-0acfea3f0cc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9298-01001439298015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0143-9298-100014392981010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01) 2011-03-310000-00-00NoNoCurrent