Prescription drug · ANDA
Tacrolimus NDC 68084-449
Tacrolimus .5 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-449-01 | 6808404490168084044901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-449-01) / 1 CAPSULE in 1 BLISTER PACK (68084-449-11)Marketed from Aug 3, 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
- American Health PackagingNDC labeler code 68084
- 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 68084-449_249a483c-c5c4-11c3-e063-6394a90a0e2eSPL ID 249a483c-c5c4-11c3-e063-6394a90a0e2eSPL set ID 93d03943-0655-44f6-b494-57bd1e336a34RxCUI 198377, 198378, 313190UNII 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
N468084044901followed by a unit qualifier and the quantityPackage 68084-0449-01. 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 transplant…
Excerpt only. Read the full label for complete information.
About NDC 68084-449
- What is NDC 68084-449?
- 68084-449 is the product NDC for Tacrolimus, Tacrolimus .5 mg/1 capsule, listed with the FDA by American Health Packaging. 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?
- American Health Packaging, NDC labeler code 68084. 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 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 | 55111-527 |
| 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 |