Tacrolimus
- Product NDC
- 67877-278
- 11-digit product format
- 678770278
- Labeler code
- 67877
- Product ID
- 67877-278_46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA203740
- Marketing category
- ANDA
- Marketing start
- 2020-11-13
- Substance
- TACROLIMUS
- Active strength
- .5 mg/1
- 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 table| Ingredient | Strength |
|---|
| TACROLIMUS | .5 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 |
|---|
| 67877-278-01 | Tacrolimus | 100 in 1 BOTTLE | CAPSULE | 100 | | 26 |
| 67877-278-33 | Tacrolimus | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 26 |
| 67877-278-33 | Tacrolimus | 50 in 1 CARTON | CAPSULE | 50 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-278 | TACROLIMUS CAPSULE [ASCEND LABORATORIES, LLC] | 24 | Current NDC, Legacy NDC, 3 package rows | 20250507_55467f4b-8437-43a3-b6d9-1bc2a13b4c11.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-278-01 | 67877027801 | 100 CAPSULE in 1 BOTTLE (67877-278-01) | 100 capsule | 2020-11-13 | 0000-00-00 | No | No | Current |
| 67877-278-33 | 67877027833 | 50 BLISTER PACK in 1 CARTON (67877-278-33) / 1 CAPSULE in 1 BLISTER PACK | 50 blister pack | 2020-11-13 | 0000-00-00 | No | No | Current |