NDC 50222-203
Protopic
Tacrolimus
Protopic is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Leo Pharma Inc.. The primary component is Tacrolimus.
| Product ID | 50222-203_29ab3181-aa34-47d1-9508-e42570673ac3 |
| NDC | 50222-203 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Protopic |
| Generic Name | Tacrolimus |
| Dosage Form | Ointment |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2000-12-08 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050777 |
| Labeler Name | LEO Pharma 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 50222-203-10
1 TUBE in 1 CARTON (50222-203-10) > 100 g in 1 TUBE
| Marketing Start Date | 2016-08-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50222-203-10 [50222020310]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-08-19 |
NDC 50222-203-60 [50222020360]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-08-19 |
NDC 50222-203-30 [50222020330]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-08-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TACROLIMUS | .3 mg/g |
OpenFDA Data
| SPL SET ID: | 51218de3-dabc-4972-9c5b-750c8b1d8083 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Calcineurin Inhibitors [MoA]
NDC Crossover Matching brand name "Protopic" or generic name "Tacrolimus"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0469-5202 | Protopic | Protopic |
| 0469-5201 | Protopic | Protopic |
| 50222-203 | Protopic | Protopic |
| 50222-211 | Protopic | Protopic |
| 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 |
Trademark Results [Protopic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROTOPIC 74524209 2127943 Live/Registered |
LEO PHARMA A/S 1994-05-12 |
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