Tacrolimus NDC 85972-103

NDC codes

FDA NDC Directory

Product NDC (as listed)85972-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85972-0103Add 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
85972-103-01	85972010301	100 CAPSULE in 1 BOTTLE (85972-103-01)Marketed from Aug 7, 2025
85972-103-30	85972010330	30 CAPSULE in 1 BOTTLE (85972-103-30)Marketed from Aug 7, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Tacrolimus
Generic name (nonproprietary): tacrolimus
Active ingredients: Tacrolimus — 5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Stellon Biotech Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213112
Marketing start: Aug 7, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 85972-103_53396094-b61b-4383-a680-82974cc9c159SPL ID 53396094-b61b-4383-a680-82974cc9c159SPL set ID 6b89e8a4-9f11-42e3-8e79-fe617e7c461fRxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0385972101017, 0385972102014
Pharmacologic class: Calcineurin Inhibitor Immunosuppressant

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

N485972010301 followed by a unit qualifier and the quantity

Package 85972-0103-01. 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 Jul 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )] , liver transplant [see Clinical Studies ( 14.2 )] , or heart transplant [see Clinical Studies ( 14.3 )] in combination with other immunosuppressants. Additional information pertaining to use i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213112

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

FDA NDC Directory listings under ANDA 213112
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	CONCORD BIOTECH LIMITED	68254-5005
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	CONCORD BIOTECH LIMITED	68254-5004
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	CONCORD BIOTECH LIMITED	68254-5006
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Stellon Biotech Inc.	85972-101
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Stellon Biotech Inc.	85972-102