NDC 0469-5202
Protopic
Tacrolimus
Protopic is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us Inc.. The primary component is Tacrolimus.
| Product ID | 0469-5202_1c7fad5d-b5aa-4b0f-8767-199fc973bd67 |
| NDC | 0469-5202 |
| 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 End Date | 2020-05-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050777 |
| Labeler Name | Astellas Pharma US Inc. |
| Substance Name | TACROLIMUS |
| Active Ingredient Strength | 1 mg/g |
| Pharm Classes | Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] |
| NDC Exclude Flag | N |
Packaging
NDC 0469-5202-11
1 TUBE in 1 CARTON (0469-5202-11) > 100 g in 1 TUBE
| Marketing Start Date | 2000-12-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0469-5202-02 [00469520202]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2000-12-08 |
| Marketing End Date | 2020-05-31 |
NDC 0469-5202-30 [00469520230]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2000-12-08 |
| Marketing End Date | 2020-05-31 |
NDC 0469-5202-60 [00469520260]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2000-12-08 |
| Marketing End Date | 2020-05-31 |
NDC 0469-5202-11 [00469520211]
Protopic OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050777 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2000-12-08 |
| Marketing End Date | 2020-05-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TACROLIMUS | 1 mg/g |
OpenFDA Data
| SPL SET ID: | 8c2e5036-5f1b-4e71-bf87-5faef295fa96 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Calcineurin Inhibitors [MoA]
- 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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