Tacrolimus
- Product NDC
- 48433-093
- 11-digit product format
- 484330093
- Labeler code
- 48433
- Product ID
- 48433-093_4ee47a06-cf78-3bca-e063-6394a90ad20a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA090596
- Marketing category
- ANDA
- Marketing start
- 2026-03-13
- 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 |
|---|
| 48433-093-01 | Tacrolimus | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 3 |
| 48433-093-20 | Tacrolimus | 100 in 1 CARTON | CAPSULE | 100 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-093-01 | 48433009301 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-093-20 | 48433009320 | 100 BLISTER PACK in 1 CARTON (48433-093-20) / 1 CAPSULE in 1 BLISTER PACK (48433-093-01) | 100 blister pack | 2026-03-13 | No | No | Historical |