What is NDC 0378-2895?

0378-2895 is the product NDC for Ferric Citrate, Tetraferric tricitrate decahydrate 210 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Tetraferric tricitrate decahydrate.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ferric Citrate?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ferric Citrate NDC 0378-2895 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-2895Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-2895Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-2895-20	0037828952000378289520	200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)Marketed from Mar 20, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ferric Citrate
Generic name (nonproprietary): ferric citrate
Active ingredients: Tetraferric tricitrate decahydrate — 210 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 205874
Marketing start: Mar 20, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571fSPL ID 8e8396fa-288b-402e-82b0-b1007d1b571fSPL set ID 8e8396fa-288b-402e-82b0-b1007d1b571fRxCUI 1594680UNII Q91187K011
Pharmacologic class: Parenteral Iron Replacement; Phosphate Binder

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378289520 followed by a unit qualifier and the quantity

Package 00378-2895-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 23, 2024.

Indications (excerpt from the label)

Ferric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Ferric citrate tablets are an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. ( 1 ) 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric citrate tablets are indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. 1.2 Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Ferric citrate tablets are indicated for the treatment of iron deficiency anemia in adult …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-2895

What is NDC 0378-2895?: 0378-2895 is the product NDC for Ferric Citrate, Tetraferric tricitrate decahydrate 210 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ferric Citrate.
What is the active ingredient?: Tetraferric tricitrate decahydrate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ferric Citrate?: 1 other product NDC are listed under this name. See all Ferric Citrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ferric Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ferric Citrate	Ferric citrate 210 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-2996	00480-2996-97

Other NDCs under NDA 205874

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 205874
Product	Strength	Form · route	Labeler	Product NDC
Auryxiaferric citrate	Tetraferric tricitrate decahydrate 210 mg/1	Tablet, Film coatedOral	Akebia Therapeutics, Inc.	59922-631