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 | 0078121040100781210401 | 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.NDC labeler code 0781
- 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.
About NDC 0781-2104
- What is NDC 0781-2104?
- 0781-2104 is the product NDC for Tacrolimus, Tacrolimus 5 mg/1 capsule, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tacrolimus.
- What is the active ingredient?
- Tacrolimus.
- Who is the labeler?
- Sandoz Inc., NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tacrolimus?
- 93 other product NDCs are listed under this name. See all Tacrolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tacrolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | AvPAK | 50268-736 | 50268-0736-15 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | AvPAK | 50268-737 | 50268-0737-15 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-092 | 48433-0092-20 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-093 | 48433-0093-20 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-094 | 48433-0094-20 |
| Tacrolimus | Tacrolimus .5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2780 | 69238-2780-03 |
| Tacrolimus | Tacrolimus 1 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2781 | 69238-2781-03 |
| Tacrolimus | Tacrolimus 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2782 | 69238-2782-03 |
| Tacrolimus | Tacrolimus 5 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals, LLC | 14789-135 | 14789-0135-05 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Stellon Biotech Inc. | 85972-101 | 85972-0101-0185972-0101-30 |
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 .5 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2102 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Sandoz Inc. | 0781-2103 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5596 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8723 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8725 |
| Tacrolimus | Tacrolimus 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8726 |
| Tacrolimus | Tacrolimus .5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9581 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Direct_Rx | 72189-536 |
| Tacrolimus | Tacrolimus 1 mg/1 | CapsuleOral | Proficient Rx LP | 82804-032 |