Tacrolimus
- Product NDC
- 43817-421
- 11-digit product format
- 438170421
- Labeler code
- 43817
- Product ID
- 43817-421_778cec6b-16f1-47b0-9c97-113ea026b5e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Panacea Biotec Limited
- Application
- ANDA090802
- Marketing category
- ANDA
- Marketing start
- 2016-02-26
- 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 |
|---|
| 43817-421-01 | Tacrolimus | 100 in 1 BOTTLE | CAPSULE, GELATIN COATED | 100 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43817-421 | TACROLIMUS CAPSULE, GELATIN COATED [PANACEA BIOTEC LIMITED] | 14 | Current NDC, Legacy NDC, 1 package rows | 20241211_bd9fea26-0236-d437-c7df-4b7636210875.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43817-421-01 | 43817042101 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01) | 2016-02-26 | 0000-00-00 | No | No | Current |