Prescription drug · ANDA
tacrolimus (Tacrolimus extended-release capsules) NDC 71432-2001
Tacrolimus .5 mg/1 · Capsule, Coated, Extended release · Oral · Chengdu Suncadia Medicine Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71432-2001-1 | 7143220010171432200101 | 1 BAG in 1 CARTON (71432-2001-1) / 5 BLISTER PACK in 1 BAG / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 25, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- tacrolimus
- Generic name (nonproprietary)
- tacrolimus extended-release capsules
- Active ingredients
- Tacrolimus — .5 mg/1
- Dosage form
- Capsule, Coated, Extended release
- Route
- Oral
- Labeler
- Chengdu Suncadia Medicine Co., Ltd.NDC labeler code 71432
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215012
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 71432-2001_102bdf7c-9d79-0124-e063-6394a90aced9SPL ID 102bdf7c-9d79-0124-e063-6394a90aced9SPL set ID 08cf2861-2483-405d-a872-a88a5c235f9aRxCUI 1431971, 1431980, 1431985UNII WM0HAQ4WNM
- Pharmacologic class
- Calcineurin Inhibitor Immunosuppressant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471432200101followed by a unit qualifier and the quantityPackage 71432-2001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact [see Clinical Studies ( 14.1 ), ( 14.2 )] . Pediatric use information is approved for Astellas Pharma US, Inc.'s ASTAGRAF XL (tacrolimus extended-release capsules). However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immun…
Excerpt only. Read the full label for complete information.
About NDC 71432-2001
- What is NDC 71432-2001?
- 71432-2001 is the product NDC for tacrolimus (tacrolimus extended-release capsules), Tacrolimus .5 mg/1 capsule, coated, extended release, listed with the FDA by Chengdu Suncadia Medicine Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- tacrolimus (Tacrolimus extended-release capsules).
- What is the active ingredient?
- Tacrolimus.
- Who is the labeler?
- Chengdu Suncadia Medicine Co., Ltd., NDC labeler code 71432. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for tacrolimus?
- 93 other product NDCs are listed under this name. See all tacrolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other tacrolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | AvPAK | 50268-736 | 50268-0736-15 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | AvPAK | 50268-737 | 50268-0737-15 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-092 | 48433-0092-20 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-093 | 48433-0093-20 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-094 | 48433-0094-20 |
| Tacrolimus | Tacrolimus .5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2780 | 69238-2780-03 |
| Tacrolimus | Tacrolimus 1 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2781 | 69238-2781-03 |
| Tacrolimus | Tacrolimus 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2782 | 69238-2782-03 |
| Tacrolimus | Tacrolimus 5 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals, LLC | 14789-135 | 14789-0135-05 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-101 | 85972-0101-0185972-0101-30 |
Other NDCs under ANDA 215012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tacrolimus | Tacrolimus .5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2780 |
| Tacrolimus | Tacrolimus 1 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2781 |
| Tacrolimus | Tacrolimus 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2782 |
| tacrolimustacrolimus extended-release capsules | Tacrolimus 1 mg/1 | Capsule, Coated, Extended releaseOral | Chengdu Suncadia Medicine Co., Ltd. | 71432-2002 |
| tacrolimustacrolimus extended-release capsules | Tacrolimus 5 mg/1 | Capsule, Coated, Extended releaseOral | Chengdu Suncadia Medicine Co., Ltd. | 71432-2003 |