Prescription drug · ANDA
Tacrolimus NDC 55154-4168
Tacrolimus 1 mg/1 · Capsule · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4168-0 | 55154416800 | 10 BLISTER PACK in 1 BAG (55154-4168-0) / 1 CAPSULE in 1 BLISTER PACKMarketed from Aug 13, 2014 |
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
- Active ingredients
- Tacrolimus — 1 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090687
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-4168_5423a9ee-e7fb-4aa4-8743-a758961e074eSPL ID 5423a9ee-e7fb-4aa4-8743-a758961e074eSPL set ID 450c3e32-6d91-4508-b064-49b293e86cecRxCUI 198377UNII WM0HAQ4WNMUPC 0055154416801
- 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
N455154416800followed by a unit qualifier and the quantityPackage 55154-4168-00. 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 capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)] or heart transplant [see Clinical Studies (14.3)] and pediatric patients receiving allogeneic liver transplant [see C…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090687
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 1 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7097 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-720 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-721 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-722 |