Prescription drug · ANDA
Tacrolimus NDC 43353-317
Tacrolimus 1 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-317-09 | 43353031709 | 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09)Marketed from May 3, 2017 |
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 — 1 mg/1
- Dosage form
- Capsule
- Route
- Oral
- 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 43353-317_815744b6-6096-4a89-8171-cdca95e10631SPL ID 815744b6-6096-4a89-8171-cdca95e10631SPL set ID 4caa20af-45a8-4365-9f06-1568afae61b1RxCUI 198377UNII 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
N443353031709followed by a unit qualifier and the quantityPackage 43353-0317-09. 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, USP are a calcineurin-inhibitor immunosuppressant indicated for: • Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants ( 1.1 , 1.2 , 1.3 ) • Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) ( 1.1 , 1.2 , 1.3 ) • Limitations of Use ( 1.4 ): • Do not use simultaneously with cyclosporine • Intravenous use reserved for patients who cannot tolerate capsules orally • Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established 1.1 Prophylaxis of Organ Rejection …
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 .5 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-817 |
| 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 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 |