Tacrolimus
- Product NDC
- 68254-5006
- 11-digit product format
- 682545006
- Labeler code
- 68254
- Product ID
- 68254-5006_76ffdfc1-7f00-49da-9578-5352593b4830
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- CONCORD BIOTECH LIMITED
- Application
- ANDA213112
- Marketing category
- ANDA
- Marketing start
- 2020-11-23
- 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 |
|---|
| 68254-5006-1 | Tacrolimus | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 68254-5006-5 | Tacrolimus | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68254-5006 | TACROLIMUS CAPSULE [CONCORD BIOTECH LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231111_823b11cb-d873-4017-a861-d22d2c5a8a49.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 |
|---|
| 68254-5006-1 | 68254500601 | 100 CAPSULE in 1 BOTTLE (68254-5006-1) | 100 capsule | 2020-11-23 | 0000-00-00 | No | No | Current |
| 68254-5006-5 | 68254500605 | 30 CAPSULE in 1 BOTTLE (68254-5006-5) | 30 capsule | 2020-11-23 | 0000-00-00 | No | No | Current |