Prescription drug · ANDA
Tacrolimus NDC 0378-2045
Tacrolimus .5 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-2045-01 | 00378204501 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2045-01)Marketed from Sep 17, 2010 |
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)
- Tacrolimus
- Generic name (nonproprietary)
- tacrolimus
- Active ingredients
- Tacrolimus — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090596
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-2045_7d8a5bab-a744-4aa7-b28f-d0c2c5a53628SPL ID 7d8a5bab-a744-4aa7-b28f-d0c2c5a53628SPL set ID 45af3eda-caaa-4478-9372-95aa65adc9b3RxCUI 198377, 198378, 313190UNII WM0HAQ4WNMUPC 0303782046014, 0303782045017, 0303782047011
- 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
N400378204501followed by a unit qualifier and the quantityPackage 00378-2045-01. 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. Additional pediatric use information is …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090596
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 | Golden State Medical Supply, Inc. | 60429-377 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-378 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-379 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-317 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-2046 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-2047 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-028 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-092 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-093 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-094 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-817 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | MylanInstitutional Inc. | 51079-818 |