Tacrolimus
- Product NDC
- 45802-390
- 11-digit product format
- 458020390
- Labeler code
- 45802
- Product ID
- 45802-390_ca08f41f-bc87-45bb-91b8-1d89adfba78f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- NDA050777
- Marketing category
- NDA
- Marketing start
- 2014-11-20
- Substance
- TACROLIMUS
- Active strength
- .3 mg/g
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tacrolimus
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TACROLIMUS | .3 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | WM0HAQ4WNM |
| Rxcui | 313189, 314266 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-390-00 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 9 | |
| 45802-390-00 | Tacrolimus | 30 g in 1 TUBE | OINTMENT | 30 | 9 | |
| 45802-390-01 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 9 | |
| 45802-390-01 | Tacrolimus | 60 g in 1 TUBE | OINTMENT | 60 | 9 | |
| 45802-390-02 | Tacrolimus | 100 g in 1 TUBE | OINTMENT | 100 | 9 | |
| 45802-390-02 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-390-00 | GM - Gram | 45802-390 | 9b660517-e56a-4c32-b5bd-e671ccdfe4cb | 1 | 2014-12-01 |
| 45802-390-01 | GM - Gram | 45802-390 | 1e4ddc76-2ba0-4481-ab58-9a6d02712192 | 1 | 2014-12-01 |
| 45802-390-02 | GM - Gram | 45802-390 | 0308e589-e8fc-4508-8566-333335c2b115 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TACROLIMUS | ACTIVE INGREDIENT | WM0HAQ4WNM | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| TACROLIMUS ANHYDROUS | ACTIVE MOIETY | Y5L2157C4J | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | TACROLIMUS OINTMENT [PERRIGO NEW YORK INC] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313189 | tacrolimus 0.03 % Topical Ointment | PSN | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 314266 | tacrolimus 0.1 % Topical Ointment | PSN | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 313189 | tacrolimus 0.0003 MG/MG Topical Ointment | SCD | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 314266 | tacrolimus 0.001 MG/MG Topical Ointment | SCD | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 313189 | tacrolimus (as tacrolimus monohydrate) 0.0003 MG/MG Topical Ointment | SY | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 314266 | tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical Ointment | SY | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 313189 | tacrolimus 0.03 % Topical Ointment | SY | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
| 314266 | tacrolimus 0.1 % Topical Ointment | SY | 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45802-390-00 | 45802039000 | 1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE | 1 tube | 2014-11-20 | 0000-00-00 | No | No | Current |
| 45802-390-01 | 45802039001 | 1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE | 1 tube | 2014-11-20 | 0000-00-00 | No | No | Current |
| 45802-390-02 | 45802039002 | 1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE | 1 tube | 2014-11-20 | 0000-00-00 | No | No | Current |