NDC 0168-0417

Tacrolimus

Tacrolimus

Tacrolimus is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Tacrolimus.

• Product ID: 0168-0417_48c43415-57e7-4aca-9e66-cc05562a3f10
• NDC: 0168-0417
• Product Type: Human Prescription Drug
• Proprietary Name: Tacrolimus
• Generic Name: Tacrolimus
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-09-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200744
• Labeler Name: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• Substance Name: TACROLIMUS
• Active Ingredient Strength: 0 mg/g
• Pharm Classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0168-0417-30

1 TUBE in 1 CARTON (0168-0417-30) > 30 g in 1 TUBE

• Marketing Start Date: 2014-09-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0417-30 [00168041730]

Tacrolimus OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA200744
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-09-09

NDC 0168-0417-99 [00168041799]

Tacrolimus OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA200744
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-09-09

NDC 0168-0417-60 [00168041760]

Tacrolimus OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA200744
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-09-09

Drug Details

Active Ingredients

Ingredient	Strength
TACROLIMUS	.3 mg/g

OpenFDA Data

• SPL SET ID: 1bf44a84-14fd-4f80-ad8a-99b1431d631f
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • WM0HAQ4WNM
• RxNorm Concept Unique ID - RxCUI:
  • 314266
  • 313189
• UPC Code:
  • 0301680416601
  • 0301680417608

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
68084-450	Tacrolimus	Tacrolimus
68084-449	Tacrolimus	Tacrolimus
68084-451	Tacrolimus	Tacrolimus
68462-534	Tacrolimus	Tacrolimus
69452-154	Tacrolimus	Tacrolimus
69452-155	Tacrolimus	Tacrolimus
69452-153	Tacrolimus	Tacrolimus
70518-1168	Tacrolimus	Tacrolimus
0781-2104	Tacrolimus	Tacrolimus
0781-2102	Tacrolimus	Tacrolimus
0781-2103	Tacrolimus	Tacrolimus
0781-9302	Tacrolimus	Tacrolimus
0781-9304	Tacrolimus	Tacrolimus
0781-9303	Tacrolimus	Tacrolimus
0904-6425	Tacrolimus	Tacrolimus
0904-6624	Tacrolimus	Tacrolimus
0904-6623	Tacrolimus	Tacrolimus
16729-041	Tacrolimus	Tacrolimus
16729-043	Tacrolimus	Tacrolimus
16729-042	Tacrolimus	Tacrolimus
43353-317	Tacrolimus	Tacrolimus
43817-423	Tacrolimus	Tacrolimus
43817-422	Tacrolimus	Tacrolimus
43817-421	Tacrolimus	Tacrolimus
45802-390	Tacrolimus	Tacrolimus
45802-700	Tacrolimus	Tacrolimus
50090-2245	Tacrolimus	Tacrolimus
51079-817	Tacrolimus	Tacrolimus
51079-818	Tacrolimus	Tacrolimus
51079-028	Tacrolimus	Tacrolimus
55111-525	Tacrolimus	Tacrolimus
55111-526	Tacrolimus	Tacrolimus
55111-527	Tacrolimus	Tacrolimus
55154-5438	Tacrolimus	Tacrolimus
55154-4395	Tacrolimus	Tacrolimus
55154-2675	Tacrolimus	Tacrolimus
60429-378	Tacrolimus	Tacrolimus
60429-377	Tacrolimus	Tacrolimus
60429-379	Tacrolimus	Tacrolimus
62175-381	Tacrolimus	Tacrolimus
62250-665	Tacrolimus	Tacrolimus
62175-380	Tacrolimus	Tacrolimus
62175-382	Tacrolimus	Tacrolimus