NDC 0469-0687
ASTAGRAF XL
Tacrolimus Extended-release Capsules
ASTAGRAF XL is a Oral Capsule, Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Tacrolimus.
| Product ID | 0469-0687_4b0d99f4-01fe-47b4-a447-70c996917f4a |
| NDC | 0469-0687 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ASTAGRAF XL |
| Generic Name | Tacrolimus Extended-release Capsules |
| Dosage Form | Capsule, Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-07-19 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204096 |
| Labeler Name | Astellas Pharma US, Inc. |
| Substance Name | TACROLIMUS |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 0469-0687-11
5 BLISTER PACK in 1 CARTON (0469-0687-11) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK
| Marketing Start Date | 2013-07-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0469-0687-73 [00469068773]
ASTAGRAF XL CAPSULE, COATED, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA204096 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-07-19 |
NDC 0469-0687-11 [00469068711]
ASTAGRAF XL CAPSULE, COATED, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA204096 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-07-19 |
| Marketing End Date | 2019-06-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TACROLIMUS | 5 mg/1 |
OpenFDA Data
| SPL SET ID: | 550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Calcineurin Inhibitors [MoA]
NDC Crossover Matching brand name "ASTAGRAF XL" or generic name "Tacrolimus Extended-release Capsules"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0469-0647 | ASTAGRAF XL | tacrolimus extended-release capsules |
| 0469-0677 | ASTAGRAF XL | tacrolimus extended-release capsules |
| 0469-0687 | ASTAGRAF XL | tacrolimus extended-release capsules |
Trademark Results [ASTAGRAF XL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASTAGRAF XL 85925271 4480263 Live/Registered |
Astellas Pharma Inc. 2013-05-07 |
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