Prescription drug · NDA
Prograf (tacrolimus) NDC 0469-0617
Tacrolimus 1 mg/1 · Capsule, Gelatin coated · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-0617-73 | 00469061773 | 1 BOTTLE in 1 CARTON (0469-0617-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Apr 8, 1994 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Prograf
- Generic name (nonproprietary)
- tacrolimus
- Active ingredients
- Tacrolimus — 1 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050708
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 0469-0617_e9157663-1515-4ba3-83b5-1622cf6f0f99SPL ID e9157663-1515-4ba3-83b5-1622cf6f0f99SPL set ID 7f667de1-9dfa-4bd6-8ba0-15ee2d78873bRxCUI 108513, 108514, 108515, 198377, 198378, 198379, 261134, 313190, 2052605, 2052609, 2052703, 2052704UNII WM0HAQ4WNMUPC 0304690607731, 0304690657736, 0304691230501, 0304691330508, 0304690617730, 0304693016011
- 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
N400469061773followed by a unit qualifier and the quantityPackage 00469-0617-73. 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)
PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant PROGRAF ® is 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 )], heart transplant [see Clinical Studies ( 14.3 )], or lung transplant [see Clinical Studies ( 14.4 )] in combination with other immunosuppressants.…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050708
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.