NDC 68992-3040

Envarsus XR

Tacrolimus

Envarsus XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Veloxis Pharmaceuticals, Inc. The primary component is Tacrolimus.

• Product ID: 68992-3040_123aa480-0d98-46dc-8c45-7f528c6d3a06
• NDC: 68992-3040
• Product Type: Human Prescription Drug
• Proprietary Name: Envarsus XR
• Generic Name: Tacrolimus
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA206406
• Labeler Name: Veloxis Pharmaceuticals, Inc
• Substance Name: TACROLIMUS
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68992-3040-1

1 POUCH in 1 CARTON (68992-3040-1) > 1 BOTTLE in 1 POUCH > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2015-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68992-3040-1 [68992304001]

Envarsus XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA206406
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-01

NDC 68992-3040-3 [68992304003]

Envarsus XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA206406
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-01

Drug Details

Active Ingredients

Ingredient	Strength
TACROLIMUS	4 mg/1

OpenFDA Data

• SPL SET ID: de2315b0-6344-43ac-9aea-3e3b68d828e7
• Manufacturer:
  • Veloxis Pharmaceuticals, Inc
• UNII:
  • WM0HAQ4WNM
• RxNorm Concept Unique ID - RxCUI:
  • 1664434
  • 1664461
  • 1664463
  • 1664458
  • 1664440
  • 1664456
• UPC Code:
  • 0368992304019
  • 0368992307515
  • 0368992301018
  • 0368992304033
  • 0368992307539
  • 0368992301032

Pharmacological Class

• Calcineurin Inhibitor Immunosuppressant [EPC]
• Calcineurin Inhibitors [MoA]

NDC Crossover Matching brand name "Envarsus XR" or generic name "Tacrolimus"

NDC	Brand Name	Generic Name
68992-3010	Envarsus XR	Envarsus XR
68992-3075	Envarsus XR	Envarsus XR
68992-3040	Envarsus XR	Envarsus XR
0469-0607	Prograf	Tacrolimus
0469-0617	Prograf	Tacrolimus
0469-0657	Prograf	Tacrolimus
0093-3428	Tacrolimus	tacrolimus
0093-3429	Tacrolimus	tacrolimus
0168-0416	Tacrolimus	tacrolimus
0168-0417	Tacrolimus	tacrolimus
0378-2045	Tacrolimus	Tacrolimus
0378-2046	Tacrolimus	Tacrolimus
0378-2047	Tacrolimus	Tacrolimus