Prescription drug · NDA
Astagraf XL (tacrolimus extended-release capsules) NDC 0469-0687
Tacrolimus 5 mg/1 · Capsule, Coated, Extended release · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-0687-73 | 00469068773 | 1 BOTTLE in 1 CARTON (0469-0687-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 19, 2013 |
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)
- Astagraf XL
- Generic name (nonproprietary)
- tacrolimus extended-release capsules
- Active ingredients
- Tacrolimus — 5 mg/1
- Dosage form
- Capsule, Coated, Extended release
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204096
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 0469-0687_4ecfe626-bf9c-4889-a1d4-64b03d60eaf8SPL ID 4ecfe626-bf9c-4889-a1d4-64b03d60eaf8SPL set ID 550a5cd4-fbf2-4c09-b577-6bde8fcbdf6eRxCUI 1431971, 1431977, 1431980, 1431982, 1431985, 1431987UNII 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
N400469068773followed by a unit qualifier and the quantityPackage 00469-0687-73. 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)
ASTAGRAF XL ® is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 ), ( 14.2 )]. ASTAGRAF XL is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact. ( 1 , 8.4 , 14.1 , 14.2 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204096
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 |
|---|---|---|---|---|
| Astagraf XLtacrolimus extended-release capsules | Tacrolimus .5 mg/1 | Capsule, Coated, Extended releaseOral | Astellas Pharma US, Inc. | 0469-0647 |
| Astagraf XLtacrolimus extended-release capsules | Tacrolimus 1 mg/1 | Capsule, Coated, Extended releaseOral | Astellas Pharma US, Inc. | 0469-0677 |