Tacrolimus
- Product NDC
- 0904-6623
- 11-digit product format
- 009046623
- Labeler code
- 0904
- Product ID
- 0904-6623_9c3a81c9-20a9-4756-82ad-7ce794c760b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090509
- Marketing category
- ANDA
- Marketing start
- 2010-05-14
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TACROLIMUS | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WM0HAQ4WNM |
| Rxcui | 198378, 313190 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6623-61 | Tacrolimus | 100 in 1 CARTON | CAPSULE | 100 | | 6 |
| 0904-6623-61 | Tacrolimus | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6623 | TACROLIMUS CAPSULE [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241212_0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9.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 |
|---|
| 0904-6623-61 | 00904662361 | 100 BLISTER PACK in 1 CARTON (0904-6623-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2010-05-14 | 0000-00-00 | No | No | Current |