Tacrolimus
- Product NDC
- 82009-164
- 11-digit product format
- 820090164
- Labeler code
- 82009
- Product ID
- 82009-164_3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA090509
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- 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 |
|---|
| 82009-164-01 | Tacrolimus | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-164 | TACROLIMUS CAPSULE [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, 1 package rows | 20250402_23b7b4d7-1431-e9f2-43ba-eabd169dc2dd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-164-01 | 82009016401 | 100 CAPSULE in 1 BOTTLE (82009-164-01) | 100 capsule | 2025-06-01 | No | No | Current |