Tacrolimus NDC 16729-041

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-041Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0041Add 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
16729-041-01	16729004101	100 CAPSULE in 1 BOTTLE (16729-041-01)Marketed from Sep 30, 2011

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: Accord Healthcare Inc.
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 16729-041_3622f4f5-48bd-9035-e063-6294a90afac2SPL ID 3622f4f5-48bd-9035-e063-6294a90afac2SPL set ID bd447ffa-9196-4c3c-accf-5adf29b84665RxCUI 2665161, 2665162, 2665163UNII 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

N416729004101 followed by a unit qualifier and the quantity

Package 16729-0041-01. 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 Jun 2, 2025. This label includes a boxed warning.

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 1 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-042
Tacrolimus	Tacrolimus 5 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-043
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9325