Prescription drug · ANDA
Tacrolimus NDC 63629-8725
Tacrolimus .5 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8725-1 | 63629872501 | 100 CAPSULE in 1 BOTTLE (63629-8725-1)Marketed from Sep 5, 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
- Active ingredients
- Tacrolimus — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065461
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-8725_f9061fe9-c3c8-462e-b6d0-dd120bc56702SPL ID f9061fe9-c3c8-462e-b6d0-dd120bc56702SPL set ID f21115e2-1d02-4bce-9c13-bf593a52a12fRxCUI 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
N463629872501followed by a unit qualifier and the quantityPackage 63629-8725-01. 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 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 t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065461
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 | Bryant Ranch Prepack | 63629-9581 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2102 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2103 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2104 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5596 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Direct_Rx | 72189-536 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Proficient Rx LP | 82804-032 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8723 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8726 |