Prescription drug · ANDA
Tacrolimus NDC 55154-4080
Tacrolimus 1 mg/1 · Capsule · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4080-8 | 55154408008 | 2000 CAPSULE in 1 BOTTLE (55154-4080-8)Marketed from Dec 23, 2020 |
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 212297
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-4080_ca8ee944-9f6f-4fe2-8d52-391d163301adSPL ID ca8ee944-9f6f-4fe2-8d52-391d163301adSPL set ID e898ee90-faae-42a8-b652-be1c8730d856RxCUI 198377UNII WM0HAQ4WNMUPC 0355154408081
- 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
N455154408008followed by a unit qualifier and the quantityPackage 55154-4080-08. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212297
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 | CapsuleOral | Biocon Pharma Inc. | 70377-014 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-015 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-016 |