Prescription drug · ANDA
Tacrolimus NDC 0904-6624
Tacrolimus 5 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6624-61 | 00904662461 | 100 BLISTER PACK in 1 CARTON (0904-6624-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from May 14, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090509
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-6624_f198313f-4b80-4469-b81e-de3ec7fe2bf2SPL ID f198313f-4b80-4469-b81e-de3ec7fe2bf2SPL set ID 0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9RxCUI 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
N400904662461followed by a unit qualifier and the quantityPackage 00904-6624-61. 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, or 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 )] , heart transplant [ see Clinical Studies ( 14.3 )] , and pediatric patients receiving allogeneic liver trans…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090509
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 | Quallent Pharmaceuticals Health LLC | 82009-054 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | American Health Packaging | 68084-451 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | American Health Packaging | 68084-449 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | American Health Packaging | 68084-450 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-165 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-164 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | AvPAK | 50268-736 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | AvPAK | 50268-737 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-527 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-525 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-526 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6623 |