Prescription drug · ANDA
Tacrolimus NDC 55111-527
Tacrolimus 5 mg/1 · Capsule · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-527-01 | 5511105270155111052701 | 1 BOTTLE in 1 CARTON (55111-527-01) / 100 CAPSULE in 1 BOTTLEMarketed from May 14, 2010 | |
| 55111-527-05 | 5511105270555111052705 | 1 BOTTLE in 1 CARTON (55111-527-05) / 500 CAPSULE in 1 BOTTLEMarketed from May 14, 2010 | |
| 55111-527-30 | 5511105273055111052730 | 1 BOTTLE in 1 CARTON (55111-527-30) / 30 CAPSULE in 1 BOTTLEMarketed from May 14, 2010 | |
| 55111-527-78 | 5511105277855111052778 | 10 BLISTER PACK in 1 CARTON (55111-527-78) / 10 CAPSULE in 1 BLISTER PACK (55111-527-79)Marketed from May 14, 2010 |
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/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- 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 55111-527_706bafff-d629-291c-5ce5-83d74a638860SPL ID 706bafff-d629-291c-5ce5-83d74a638860SPL set ID 61dee012-43af-0e9a-3843-9b9b91e022c4RxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0355111527015, 0355111525011, 0355111526018
- 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
N455111052701followed by a unit qualifier and the quantityPackage 55111-0527-01. 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 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.
About NDC 55111-527
- What is NDC 55111-527?
- 55111-527 is the product NDC for Tacrolimus, Tacrolimus 5 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 4 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 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 .5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6623 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6624 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-054 |
| 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 | American Health Packaging | 68084-451 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | AvPAK | 50268-737 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-164 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-165 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | AvPAK | 50268-736 |
| 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 |