Tacrolimus is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Tacrolimus.
| Product ID | 16729-422_8a6edc94-b147-a030-e053-2995a90a5e1b |
| NDC | 16729-422 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tacrolimus |
| Generic Name | Tacrolimus |
| Dosage Form | Ointment |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2019-05-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211688 |
| Labeler Name | Accord Healthcare Inc. |
| Substance Name | TACROLIMUS |
| Active Ingredient Strength | 1 mg/g |
| Pharm Classes | Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-06-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2019-05-31 |
| Marketing Category | ANDA |
| Application Number | ANDA211688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2019-06-05 |
| Marketing Category | ANDA |
| Application Number | ANDA211688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2019-05-31 |
| Ingredient | Strength |
|---|---|
| TACROLIMUS | 1 mg/g |
| 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 |