Prescription drug · ANDA
Tacrolimus NDC 43817-421
Tacrolimus .5 mg/1 · Capsule, Gelatin coated · Oral · Panacea Biotec Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43817-421-01 | 4381704210143817042101 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01)Marketed from Feb 26, 2016 |
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, Gelatin coated
- Route
- Oral
- Labeler
- Panacea Biotec LimitedNDC labeler code 43817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090802
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 43817-421_778cec6b-16f1-47b0-9c97-113ea026b5e5SPL ID 778cec6b-16f1-47b0-9c97-113ea026b5e5SPL set ID bd9fea26-0236-d437-c7df-4b7636210875RxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0343817423014, 0343817421010, 0343817422017
- 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
N443817042101followed by a unit qualifier and the quantityPackage 43817-0421-01. 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 immuno-suppressant 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 transplants [see Clinical Studies ( 14.2 )], or heart transplant [see Clinical Studies ( 14.3 )], in combination with other immunosuppressants.
Excerpt only. Read the full label for complete information.
About NDC 43817-421
- What is NDC 43817-421?
- 43817-421 is the product NDC for Tacrolimus, Tacrolimus .5 mg/1 capsule, gelatin coated, listed with the FDA by Panacea Biotec Limited. 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?
- Panacea Biotec Limited, NDC labeler code 43817. 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 090802
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 | Capsule, Gelatin coatedOral | Panacea Biotec Limited | 43817-422 |
| Tacrolimus | Tacrolimus 5 mg/1 | Capsule, Gelatin coatedOral | Panacea Biotec Limited | 43817-423 |
| Tacrolimus | Tacrolimus .5 mg/1 | Capsule, Gelatin coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-798 |
| Tacrolimus | Tacrolimus 1 mg/1 | Capsule, Gelatin coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-799 |
| Tacrolimus | Tacrolimus 5 mg/1 | Capsule, Gelatin coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-800 |