Tacrolimus NDC 67877-280

NDC codes

FDA NDC Directory

Product NDC (as listed)67877-280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67877-0280Add 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
67877-280-01	67877028001	100 CAPSULE in 1 BOTTLE (67877-280-01)Marketed from Nov 13, 2020
67877-280-33	67877028033	50 BLISTER PACK in 1 CARTON (67877-280-33) / 1 CAPSULE in 1 BLISTER PACKMarketed from Nov 13, 2020

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: Ascend Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203740
Marketing start: Nov 13, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 67877-280_46ed8f56-e67b-4faa-9ad3-1c07ae46e8acSPL ID 46ed8f56-e67b-4faa-9ad3-1c07ae46e8acSPL set ID 55467f4b-8437-43a3-b6d9-1bc2a13b4c11RxCUI 198377, 198378, 313190UNII WM0HAQ4WNM
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

N467877028001 followed by a unit qualifier and the quantity

Package 67877-0280-01. 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 Dec 18, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Tacrolimus capsule is 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 pediatric use information is …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203740

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

FDA NDC Directory listings under ANDA 203740
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-278
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-279