NDC 43353-178

Prograf

Tacrolimus

Prograf is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Tacrolimus.

• Product ID: 43353-178_b0d8a6ff-5163-4f29-abcd-8318b92bbef9
• NDC: 43353-178
• Product Type: Human Prescription Drug
• Proprietary Name: Prograf
• Generic Name: Tacrolimus
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 1994-04-08
• Marketing Category: NDA / NDA
• Application Number: NDA050708
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• 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: 2019-12-31

Packaging

NDC 43353-178-09

9000 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-178-09)

• Marketing Start Date: 1994-04-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-178-60 [43353017860]

Prograf CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA050708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-04-08
• Inactivation Date: 2020-01-31

NDC 43353-178-09 [43353017809]

Prograf CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA050708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-04-08
• Inactivation Date: 2020-01-31

NDC 43353-178-53 [43353017853]

Prograf CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA050708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-04-08
• Inactivation Date: 2020-01-31

NDC 43353-178-80 [43353017880]

Prograf CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA050708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-04-08
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TACROLIMUS	1 mg/1

OpenFDA Data

• SPL SET ID: 1e56c550-1c2b-4177-8e49-26303e9e335f
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • WM0HAQ4WNM
• RxNorm Concept Unique ID - RxCUI:
  • 108513
  • 198377

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