Tacrolimus NDC 70377-016

NDC codes

FDA NDC Directory

Product NDC (as listed)70377-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70377-0016Add 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
70377-016-11	70377001611	100 CAPSULE in 1 BOTTLE (70377-016-11)Marketed from Dec 23, 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: Biocon Pharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212297
Marketing start: Dec 23, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 70377-016_640e066c-f2a3-5fb2-4b55-4ac9aec0d31bSPL ID 640e066c-f2a3-5fb2-4b55-4ac9aec0d31bSPL set ID 0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60fRxCUI 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

N470377001611 followed by a unit qualifier and the quantity

Package 70377-0016-11. 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 Sep 28, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Tacrolimus capsules are 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 transplants [ see Clinical Studies (14.2) ] and heart transplant [ see Clinical Studies (14.3) ] , and pediatric patients receiving allogeneic liver trans…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212297

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

FDA NDC Directory listings under ANDA 212297
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-014
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-015
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-4080