Prescription drug · ANDA
Tacrolimus NDC 51079-817
Tacrolimus .5 mg/1 · Capsule · Oral · MylanInstitutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-817-20 | 51079081720 | 100 BLISTER PACK in 1 CARTON (51079-817-20) / 1 CAPSULE in 1 BLISTER PACK (51079-817-01)Marketed from Nov 15, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- MylanInstitutional Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090596
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 51079-817_3a877ea9-889b-d064-e063-6294a90ad291SPL ID 3a877ea9-889b-d064-e063-6294a90ad291SPL set ID 5f742224-618e-4f4c-bdec-7693be99c697RxCUI 198377, 198378, 313190UNII 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
N451079081720followed by a unit qualifier and the quantityPackage 51079-0817-20. 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 capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic 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) ] , and heart transplant [see Clinical Studies (14.3) ] , and pediatric patients receiving allogeneic liver tra…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090596
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 | Safecor Health LLC | 48433-093 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-092 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-094 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-818 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-378 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-377 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-317 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-379 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-2045 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-2046 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-2047 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-028 |