Prescription drug · ANDA
Tacrolimus NDC 0781-2104
Tacrolimus 5 mg/1 · Capsule · Oral · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2104-01 | 00781210401 | 100 CAPSULE in 1 BOTTLE (0781-2104-01)Marketed from Aug 10, 2009 |
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
- Sandoz Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065461
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-2104_e8767e7d-c178-4939-b486-0215796e5d9bSPL ID e8767e7d-c178-4939-b486-0215796e5d9b
- 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
N400781210401followed by a unit qualifier and the quantityPackage 00781-2104-01. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 065461
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 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5596 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2102 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2103 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Direct_Rx | 72189-536 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Proficient Rx LP | 82804-032 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8725 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8723 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8726 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9581 |