Tacrolimus NDC 82983-401

NDC codes

FDA NDC Directory

Product NDC (as listed)82983-401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82983-0401Add 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
82983-401-10	82983040110	100 CAPSULE in 1 BOTTLE (82983-401-10)Marketed from Jan 31, 2023

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 — 1 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Ajenat Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206651
Marketing start: Jan 31, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 82983-401_6b08720e-dc88-4731-8863-af564a293b5aSPL ID 6b08720e-dc88-4731-8863-af564a293b5aSPL set ID ca08d4aa-3de2-4a9d-9554-6288e5d36f29RxCUI 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

N482983040110 followed by a unit qualifier and the quantity

Package 82983-0401-10. 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 29, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for • Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants ( 1.1 , 1.2 , 1.3 ) • Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) ( 1.1 , 1.2 , 1.3 ) • Limitations of Use ( 1.4 ): • Do not use simultaneously with cyclosporine • Intravenous use reserved for patients who can not tolerate capsules orally • Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established 1.1 Prophylaxis of Organ Rejection in Kidney Trans…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206651

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

FDA NDC Directory listings under ANDA 206651
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Ajenat Pharmaceuticals LLC	82983-400
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	Ajenat Pharmaceuticals LLC	82983-402
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	BPI Labs LLC	54288-133
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	BPI Labs LLC	54288-135
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	BPI Labs LLC	54288-134