Tacrolimus
- Product NDC
- 85972-102
- 11-digit product format
- 859720102
- Labeler code
- 85972
- Product ID
- 85972-102_d42f3a56-8ff1-44ab-9811-9a9404e83fba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Stellon Biotech Inc.
- Application
- ANDA213112
- Marketing category
- ANDA
- Marketing start
- 2025-08-07
- Substance
- TACROLIMUS
- Active strength
- 1 mg/1
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tacrolimus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TACROLIMUS | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WM0HAQ4WNM |
| Rxcui | 198377, 198378, 313190 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85972-102-01 | Tacrolimus | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 85972-102-30 | Tacrolimus | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85972-102-01 | 85972010201 | 100 CAPSULE in 1 BOTTLE (85972-102-01) | 100 capsule | 2025-08-07 | No | No | Current |
| 85972-102-30 | 85972010230 | 30 CAPSULE in 1 BOTTLE (85972-102-30) | 30 capsule | 2025-08-07 | No | No | Current |