Tacrolimus
- Product NDC
- 69238-2780
- 11-digit product format
- 692382780
- Labeler code
- 69238
- Product ID
- 69238-2780_05c70395-3037-4e8a-be20-dd9f4aebbe06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA215012
- Marketing category
- ANDA
- Marketing start
- 2026-03-02
- Substance
- TACROLIMUS
- Active strength
- .5 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WM0HAQ4WNM |
| Rxcui | 1431971, 1431980, 1431985 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-2780-3 | Tacrolimus | 3 in 1 BAG | CAPSULE, EXTENDED RELEASE | 3 | | 1 |
| 69238-2780-3 | Tacrolimus | 1 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-2780-3 | 69238278003 | 1 BAG in 1 CARTON (69238-2780-3) / 3 BLISTER PACK in 1 BAG / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK | 1 bag | 2026-03-02 | No | No | Current |