Prescription drug · ANDA
Tacrolimus NDC 14789-135
Tacrolimus 5 mg/mL · Injection · Intravenous · Nexus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14789-135-05 | 1478901350514789013505 | 10 VIAL in 1 CARTON (14789-135-05) / 1 mL in 1 VIAL (14789-135-07)Marketed from Dec 1, 2025 |
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/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Nexus Pharmaceuticals, LLCNDC labeler code 14789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217108
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 14789-135_44fc0987-ff9d-3099-e063-6394a90a7a55SPL ID 44fc0987-ff9d-3099-e063-6394a90a7a55SPL set ID 9d502961-e9c0-4611-92bf-ce742a7b962cRxCUI 198379UNII WM0HAQ4WNMUPC 0314789135052
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N414789013505followed by a unit qualifier and the quantityPackage 14789-0135-05. 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 is a 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 is indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )], liver transplants [see Clinical Studies ( 14.2 )] and heart transplant [see Clinical Studies ( 14.3 )], and pediatric patients receiving allogeneic liver transplants [see Cl…
Excerpt only. Read the full label for complete information.
About NDC 14789-135
- What is NDC 14789-135?
- 14789-135 is the product NDC for Tacrolimus, Tacrolimus 5 mg/mL injection, listed with the FDA by Nexus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tacrolimus.
- What is the active ingredient?
- Tacrolimus.
- Who is the labeler?
- Nexus Pharmaceuticals, LLC, NDC labeler code 14789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tacrolimus?
- 93 other product NDCs are listed under this name. See all Tacrolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tacrolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | AvPAK | 50268-736 | 50268-0736-15 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | AvPAK | 50268-737 | 50268-0737-15 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-092 | 48433-0092-20 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-093 | 48433-0093-20 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-094 | 48433-0094-20 |
| Tacrolimus | Tacrolimus .5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2780 | 69238-2780-03 |
| Tacrolimus | Tacrolimus 1 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2781 | 69238-2781-03 |
| Tacrolimus | Tacrolimus 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2782 | 69238-2782-03 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-101 | 85972-0101-0185972-0101-30 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-102 | 85972-0102-0185972-0102-30 |