Tacrolimus
- Product NDC
- 65897-0009
- 11-digit product format
- 658970009
- Labeler code
- 65897
- Product ID
- 65897-0009_39a2918e-2da4-a843-e063-6294a90a9fec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
- Application
- ANDA210929
- Marketing category
- ANDA
- Marketing start
- 2025-07-11
- Substance
- TACROLIMUS ANHYDROUS
- 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 ANHYDROUS | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y5L2157C4J |
| Rxcui | 198377, 313190 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65897-0009-1 | Tacrolimus | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
| 65897-0009-1 | Tacrolimus | 10 in 1 BAG | CAPSULE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65897-0009-1 | 65897000901 | 1 BAG in 1 CARTON (65897-0009-1) / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK | 1 bag | 2025-07-11 | No | No | Current |