Prescription drug · ANDA
Tacrolimus NDC 48433-094
Tacrolimus 5 mg/1 · Capsule · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-094-20 | 48433009420 | 100 BLISTER PACK in 1 CARTON (48433-094-20) / 1 CAPSULE in 1 BLISTER PACK (48433-094-01)Marketed from Mar 13, 2026 |
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
- Safecor Health LLC
- 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 48433-094_4ee47a06-cf78-3bca-e063-6394a90ad20aSPL ID 4ee47a06-cf78-3bca-e063-6394a90ad20aSPL set ID 393cd10e-133c-4d6b-b024-270eb82edbb3RxCUI 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
N448433009420followed by a unit qualifier and the quantityPackage 48433-0094-20. 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 and pediatric patients receiving allogeneic liver, kidney, or heart 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 and pediatric 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) ] , in combination with other immunosuppressants. Additional pediatric use information is …
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 .5 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-377 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-378 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-379 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-317 |
| 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 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-092 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-093 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-817 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-818 |