Tacrolimus NDC 68254-5004

NDC codes

FDA NDC Directory

Product NDC (as listed)68254-5004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68254-5004Add 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
68254-5004-1	68254500401	100 CAPSULE in 1 BOTTLE (68254-5004-1)Marketed from Nov 23, 2020
68254-5004-5	68254500405	30 CAPSULE in 1 BOTTLE (68254-5004-5)Marketed from Nov 23, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: CONCORD BIOTECH LIMITED
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213112
Marketing start: Nov 23, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 68254-5004_76ffdfc1-7f00-49da-9578-5352593b4830SPL ID 76ffdfc1-7f00-49da-9578-5352593b4830SPL set ID 823b11cb-d873-4017-a861-d22d2c5a8a49RxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0368254500418, 0368254500616, 0368254500517
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

N468254500401 followed by a unit qualifier and the quantity

Package 68254-5004-01. 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 Nov 10, 2023. 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 patients receiving allogeneic liver, kidney or heart transplants, and pediatric patients receiving allogeneic liver 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 patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)] , liver transplant [see Clinical Studies (14.2)] , heart transplant [see Clinical Studies (14.3)] , and pediatric patients receiving allogeneic liver transplant …

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	68254-5006
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Stellon Biotech Inc.	85972-101
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Stellon Biotech Inc.	85972-102
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	Stellon Biotech Inc.	85972-103