Tacrolimus
- Product NDC
- 43353-317
- 11-digit product format
- 433530317
- Labeler code
- 43353
- Product ID
- 43353-317_815744b6-6096-4a89-8171-cdca95e10631
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090596
- Marketing category
- ANDA
- Marketing start
- 2015-11-18
- Substance
- TACROLIMUS
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WM0HAQ4WNM |
| Rxcui | 198377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-317-09 | Tacrolimus | 9000 in 1 BOTTLE, PLASTIC | CAPSULE | 9000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-317 | TACROLIMUS CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20171026_4caa20af-45a8-4365-9f06-1568afae61b1.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 |
|---|
| 43353-317-09 | 43353031709 | 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09) | 9000 capsule | 2017-05-03 | 0000-00-00 | No | No | Current |