Prograf (tacrolimus) NDC 0469-1330

NDC codes

FDA NDC Directory

Product NDC (as listed)0469-1330Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00469-1330Add 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
0469-1330-50	00469133050	50 PACKET in 1 CARTON (0469-1330-50) / 1 GRANULE, FOR SUSPENSION in 1 PACKETMarketed from May 24, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Prograf
Generic name (nonproprietary): tacrolimus
Active ingredients: Tacrolimus — 1 mg/1
Dosage form: Granule, For suspension
Route: Oral
Labeler: Astellas Pharma US, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210115
Marketing start: May 24, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 0469-1330_e9157663-1515-4ba3-83b5-1622cf6f0f99SPL ID e9157663-1515-4ba3-83b5-1622cf6f0f99SPL set ID 7f667de1-9dfa-4bd6-8ba0-15ee2d78873bRxCUI 108513, 108514, 108515, 198377, 198378, 198379, 261134, 313190, 2052605, 2052609, 2052703, 2052704UNII WM0HAQ4WNMUPC 0304690607731, 0304690657736, 0304691230501, 0304691330508, 0304690617730, 0304693016011
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

N400469133050 followed by a unit qualifier and the quantity

Package 00469-1330-50. 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 Aug 25, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant PROGRAF ® is indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )], liver transplant [see Clinical Studies ( 14.2 )], heart transplant [see Clinical Studies ( 14.3 )], or lung transplant [see Clinical Studies ( 14.4 )] in combination with other immunosuppressants.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 210115

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

FDA NDC Directory listings under NDA 210115
Product	Strength	Form · route	Labeler	Product NDC
Prograftacrolimus	Tacrolimus .2 mg/1	Granule, For suspensionOral	Astellas Pharma US, Inc.	0469-1230