ferric citrate

Generic: ferric citrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ferric citrate
Generic Name ferric citrate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tetraferric tricitrate decahydrate 210 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2895
Product ID 0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA205874
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

Pharmacologic Class

Classes
iron [cs] parenteral iron replacement [epc] phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03782895
Hyphenated Format 0378-2895

Supplemental Identifiers

RxCUI
1594680
UNII
Q91187K011

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ferric citrate (source: ndc)
Generic Name ferric citrate (source: ndc)
Application Number NDA205874 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 210 mg/1
source: ndc
Packaging
  • 200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)
source: ndc

Packages (1)

0378-2895-20 200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)

Ingredients (1)

tetraferric tricitrate decahydrate (210 mg/1)

Linked Drug Pages (1)

Ferric Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8e8396fa-288b-402e-82b0-b1007d1b571f", "openfda": {"unii": ["Q91187K011"], "rxcui": ["1594680"], "spl_set_id": ["8e8396fa-288b-402e-82b0-b1007d1b571f"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)", "package_ndc": "0378-2895-20", "marketing_start_date": "20250320"}], "brand_name": "Ferric Citrate", "product_id": "0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0378-2895", "generic_name": "Ferric Citrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ferric Citrate", "active_ingredients": [{"name": "TETRAFERRIC TRICITRATE DECAHYDRATE", "strength": "210 mg/1"}], "application_number": "NDA205874", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250320", "listing_expiration_date": "20261231"}