tacrolimus
- Product NDC
- 71432-2003
- 11-digit product format
- 714322003
- Labeler code
- 71432
- Product ID
- 71432-2003_102bdf7c-9d79-0124-e063-6394a90aced9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tacrolimus extended-release capsules
- Dosage form
- CAPSULE, COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Chengdu Suncadia Medicine Co., Ltd.
- Application
- ANDA215012
- Marketing category
- ANDA
- Marketing start
- 2024-01-25
- 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 | 1431971, 1431980, 1431985 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71432-2003-1 | 71432200301 | 1 BAG in 1 CARTON (71432-2003-1) / 5 BLISTER PACK in 1 BAG / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 bag | 2024-01-25 | No | No | Historical |