NDC 0469-1330

Prograf

Tacrolimus

Prograf is a Oral Granule, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Tacrolimus.

• Product ID: 0469-1330_42ba828f-429f-4270-8758-e9d1ebb7855f
• NDC: 0469-1330
• Product Type: Human Prescription Drug
• Proprietary Name: Prograf
• Generic Name: Tacrolimus
• Dosage Form: Granule, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-24
• Marketing Category: NDA / NDA
• Application Number: NDA210115
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: TACROLIMUS
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0469-1330-50

50 PACKET in 1 CARTON (0469-1330-50) > 1 GRANULE, FOR SUSPENSION in 1 PACKET

• Marketing Start Date: 2018-05-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-1330-50 [00469133050]

Prograf GRANULE, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA210115
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-24

Drug Details

Active Ingredients

Ingredient	Strength
TACROLIMUS	1 mg/1

OpenFDA Data

• SPL SET ID: 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • WM0HAQ4WNM
• RxNorm Concept Unique ID - RxCUI:
  • 198378
  • 198379
  • 2052704
  • 198377
  • 261134
  • 313190
  • 2052609
  • 2052703
  • 2052605
  • 108515
  • 108514
  • 108513
• UPC Code:
  • 0304690607731
  • 0304693016011
  • 0304690657736
  • 0304690617730

Pharmacological Class

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

NDC Crossover Matching brand name "Prograf" or generic name "Tacrolimus"

NDC	Brand Name	Generic Name
0469-0607	Prograf	Tacrolimus
0469-0617	Prograf	Tacrolimus
0469-0657	Prograf	Tacrolimus
0469-1230	Prograf	Prograf
0469-1330	Prograf	Prograf
0469-3016	Prograf	Prograf
21695-170	Prograf	Prograf
43353-178	Prograf	Prograf
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