Prescription drug · ANDA
tacrolimus NDC 16714-100
Tacrolimus 5 mg/1 · Capsule · Oral · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-100-01 | 16714010001 | 100 CAPSULE in 1 BOTTLE (16714-100-01)Marketed from Mar 31, 2021 |
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
- NORTHSTAR RX LLC
- 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 16714-100_0e68684e-7947-40a2-b17c-7919e94163a5SPL ID 0e68684e-7947-40a2-b17c-7919e94163a5SPL set ID 875f4962-557e-4e12-ad7b-cb5fb6f2a65fRxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0316714098012, 0316714099019, 0316714100012
- 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
N416714010001followed by a unit qualifier and the quantityPackage 16714-0100-01. 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 | Glenmark Pharmaceuticals Inc., USA | 68462-687 |
| tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-685 |
| tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-686 |
| tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5581 |