Envarsus XR (tacrolimus) NDC 68992-3010

NDC codes

FDA NDC Directory

Product NDC (as listed)68992-3010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68992-3010Add 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
68992-3010-1	68992301001	1 POUCH in 1 CARTON (68992-3010-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 1, 2015
68992-3010-3	68992301003	1 POUCH in 1 CARTON (68992-3010-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Sep 1, 2015

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): Envarsus XRSuffix: XR
Generic name (nonproprietary): tacrolimus
Active ingredients: Tacrolimus — 1 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Veloxis Pharmaceuticals, Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206406
Marketing start: Sep 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 68992-3010_163c129d-f4e2-484d-af96-c265c9a5e38cSPL ID 163c129d-f4e2-484d-af96-c265c9a5e38cSPL set ID de2315b0-6344-43ac-9aea-3e3b68d828e7RxCUI 1664434, 1664440, 1664456, 1664458, 1664461, 1664463UNII WM0HAQ4WNMUPC 0368992304033, 0368992301032, 0368992307539, 0368992301018, 0368992307515
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

N468992301001 followed by a unit qualifier and the quantity

Package 68992-3010-01. 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 Feb 26, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants ( 1.1 ) The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in De Novo Kidney Transplant Patients ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants [see Clinical Studies (14.1) ]. 1.2 Prophylaxis of Organ Rejection in Stable Kidney Transplant Patients Converting …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 206406

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

FDA NDC Directory listings under NDA 206406
Product	Strength	Form · route	Labeler	Product NDC
Envarsus XRtacrolimus	Tacrolimus 4 mg/1	Tablet, Extended releaseOral	Veloxis Pharmaceuticals, Inc	68992-3040
Envarsus XRtacrolimus	Tacrolimus .75 mg/1	Tablet, Extended releaseOral	Veloxis Pharmaceuticals, Inc	68992-3075