Home NDC 0480-2996 Ferric Citrate
Product NDC 0480-2996
11-digit product format 004802996
Labeler code 0480
Product ID 0480-2996_b21d112b-5910-49b0-bba4-2e4339fcc89c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ferric Citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA212563
Marketing category ANDA
Marketing start 2026-03-11
Substance FERRIC CITRATE
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 2027-12-31
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 A212563-001 FERRIC CITRATE FERRIC CITRATE EQ 210MG IRON TABLET / ORAL AB 2026-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212563-001 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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212563-001 FERRIC CITRATE EQ 210MG IRON TABLET / ORAL AB 2026-03-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212563-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Ferric Citrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC CITRATE 210 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63G354M39Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1594680 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 0480-2996-97 Ferric Citrate 200 in 1 BOTTLE TABLET, FILM COATED 200 1
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 Sample Exclude flag Status 0480-2996-97 00480299697 200 TABLET, FILM COATED in 1 BOTTLE (0480-2996-97) 2026-03-11 No No Current