Prescription drug · ANDA
tacrolimus NDC 68462-685
Tacrolimus .5 mg/1 · Capsule · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-685-01 | 68462068501 | 100 CAPSULE in 1 BOTTLE (68462-685-01)Marketed from Nov 10, 2020 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206662
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-685_13e3f94c-d4c5-4b5b-a51a-0e87eadc5718SPL ID 13e3f94c-d4c5-4b5b-a51a-0e87eadc5718SPL set ID 4b310c6b-e035-4e44-9573-4001d58b2ad5RxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0368462686010, 0368462687017, 0368462685013
- 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
N468462068501followed by a unit qualifier and the quantityPackage 68462-0685-01. 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 )] and heart transplant [see Clinical Studies ( 14.3 )] in combination with other immunosuppressants.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206662
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 | NORTHSTAR RX LLC | 16714-098 |
| tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | NORTHSTAR RX LLC | 16714-099 |
| tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | NORTHSTAR RX LLC | 16714-100 |
| tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-687 |
| tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-686 |
| tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5581 |