Ferric Citrate

Product NDC
0378-2895
11-digit product format
003782895
Labeler code
0378
Product ID
0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA205874
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-03-20
Substance
TETRAFERRIC TRICITRATE DECAHYDRATE
Active strength
210 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ferric Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAFERRIC TRICITRATE DECAHYDRATE210 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ91187K011
Rxcui1594680

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
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-2895-20Ferric Citrate200 in 1 BOTTLETABLET, FILM COATED2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2895-20EA - Each0378-289518d0d002-a17e-4cdc-b368-0d916772a23512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2895FERRIC CITRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]1Current NDC, 1 package rows20250322_8e8396fa-288b-402e-82b0-b1007d1b571f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1594680ferric citrate (as iron) 210 MG Oral TabletPSN8e8396fa-288b-402e-82b0-b1007d1b571f1
1594680ferric citrate 1000 MG Oral TabletSCD8e8396fa-288b-402e-82b0-b1007d1b571f1
1594680ferric citrate 1 GM (iron 210 MG) Oral TabletSY8e8396fa-288b-402e-82b0-b1007d1b571f1
1594680ferric citrate 1 GM Oral TabletSY8e8396fa-288b-402e-82b0-b1007d1b571f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0378-2895-2000378289520200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20) 2025-03-20NoNoHistorical