Prescription drug · ANDA
Tacrolimus NDC 85972-102
Tacrolimus 1 mg/1 · Capsule · Oral · Stellon Biotech Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85972-102-01 | 8597201020185972010201 | 100 CAPSULE in 1 BOTTLE (85972-102-01)Marketed from Aug 7, 2025 | |
| 85972-102-30 | 8597201023085972010230 | 30 CAPSULE in 1 BOTTLE (85972-102-30)Marketed from Aug 7, 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 — 1 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Stellon Biotech Inc.NDC labeler code 85972
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213112
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 85972-102_53396094-b61b-4383-a680-82974cc9c159SPL ID 53396094-b61b-4383-a680-82974cc9c159SPL set ID 6b89e8a4-9f11-42e3-8e79-fe617e7c461fRxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0385972101017, 0385972102014
- 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
N485972010201followed by a unit qualifier and the quantityPackage 85972-0102-01. 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 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 )] , or heart transplant [see Clinical Studies ( 14.3 )] in combination with other immunosuppressants. Additional information pertaining to use i…
Excerpt only. Read the full label for complete information.
About NDC 85972-102
- What is NDC 85972-102?
- 85972-102 is the product NDC for Tacrolimus, Tacrolimus 1 mg/1 capsule, listed with the FDA by Stellon Biotech Inc.. It has 2 package NDCs, 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?
- Stellon Biotech Inc., NDC labeler code 85972. 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/mL | InjectionIntravenous | Nexus Pharmaceuticals, LLC | 14789-135 | 14789-0135-05 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-101 | 85972-0101-0185972-0101-30 |
Other NDCs under ANDA 213112
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 | CONCORD BIOTECH LIMITED | 68254-5004 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | CONCORD BIOTECH LIMITED | 68254-5005 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | CONCORD BIOTECH LIMITED | 68254-5006 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-101 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-103 |