Tacrolimus NDC 63629-9325

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-9325Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-9325Add 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
63629-9325-1	63629932501	60 CAPSULE in 1 BOTTLE (63629-9325-1)Marketed from Jul 11, 2022

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 — 1 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091195
Marketing start: Sep 30, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 63629-9325_9e1bdc2a-6295-41c7-88d1-8bf1ef908f41SPL ID 9e1bdc2a-6295-41c7-88d1-8bf1ef908f41SPL set ID 54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6RxCUI 198377UNII 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

N463629932501 followed by a unit qualifier and the quantity

Package 63629-9325-01. 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 3, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Tacrolimus is 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) ], or heart transplant [see Clinical Studies (14.3) ] and pediatric patients receiving allogeneic liver transplants [see…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091195

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

FDA NDC Directory listings under ANDA 091195
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2189
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-041
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-042
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-043