Tacrolimus NDC 54288-133

NDC codes

FDA NDC Directory

Product NDC (as listed)54288-133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54288-0133Add 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
54288-133-01	54288013301	100 CAPSULE in 1 BOTTLE (54288-133-01)Marketed from Apr 8, 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: BPI Labs LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206651
Marketing start: Apr 8, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 54288-133_f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9SPL ID f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9SPL set ID 3e8bc65e-8048-4073-8e45-570330603000RxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0354288134019, 0354288133012, 0354288135016
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

N454288013301 followed by a unit qualifier and the quantity

Package 54288-0133-01. 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 Jan 6, 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 patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic 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 )] , and heart transplant [ see Clinical Studies ( 14.3 )] , and pediatric patients receiving allogeneic liver…

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 1 mg/1	CapsuleOral	Ajenat Pharmaceuticals LLC	82983-401
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	Ajenat Pharmaceuticals LLC	82983-402
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	BPI Labs LLC	54288-135
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	BPI Labs LLC	54288-134