Protopic
- Product NDC
- 0469-5202
- 11-digit product format
- 004695202
- Labeler code
- 0469
- Product ID
- 0469-5202_1c7fad5d-b5aa-4b0f-8767-199fc973bd67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Astellas Pharma US Inc.
- Application
- NDA050777
- Marketing category
- NDA
- Marketing start
- 2000-12-08
- Marketing end
- 2020-05-31
- Substance
- TACROLIMUS
- Active strength
- 1 mg/g
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| df369ad4-19d8-393a-de46-8c6255b8b360 | Product name | 8 | 20251120 |
| d2a74186-7b26-dbcc-9435-50b3d0be14ab | Product name | 2 | 20250114 |
| a64835ae-fa9d-41d8-9a93-36828ba72b96 | Product name | 3 | 20190611 |
| b4a869e4-9fcd-47bd-95e3-85e7c75f8bad | Product name | 1 | 20150819 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0469-5202-11 | GM - Gram | 0469-5202 | 93c6cd06-059f-419f-a318-e1ae44fb3faa | 1 | 2012-07-24 |
| 0469-5202-30 | GM - Gram | 0469-5202 | 49261212-91e2-47bf-8871-df4437165449 | 1 | 2012-07-24 |
| 0469-5202-60 | GM - Gram | 0469-5202 | e95b08af-25e7-46c9-92f2-37fd44c85a3e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TACROLIMUS | ACTIVE INGREDIENT | WM0HAQ4WNM | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TACROLIMUS | ACTIVE MOIETY | WM0HAQ4WNM | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | PROTOPIC (TACROLIMUS) OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 284520 | Protopic 0.1 % Topical Ointment | PSN | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 314266 | tacrolimus 0.1 % Topical Ointment | PSN | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 284520 | tacrolimus 0.001 MG/MG Topical Ointment [Protopic] | SBD | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 314266 | tacrolimus 0.001 MG/MG Topical Ointment | SCD | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 284520 | Protopic 0.001 MG/MG Topical Ointment | SY | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 284520 | Protopic 0.1 % Topical Ointment | SY | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 314266 | tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical Ointment | SY | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |
| 314266 | tacrolimus 0.1 % Topical Ointment | SY | 3b7f0fed-9046-4094-a131-29d560733e47 | 1 |