Prescription drug · ANDA
Tacrolimus NDC 69238-2782
Tacrolimus 5 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2782-3 | 69238278203 | 1 BAG in 1 CARTON (69238-2782-3) / 3 BLISTER PACK in 1 BAG / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 2, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215012
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 69238-2782_05c70395-3037-4e8a-be20-dd9f4aebbe06SPL ID 05c70395-3037-4e8a-be20-dd9f4aebbe06SPL set ID 4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3RxCUI 1431971, 1431980, 1431985UNII WM0HAQ4WNMUPC 0369238278231, 0369238278132, 0369238278033
- 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
N469238278203followed by a unit qualifier and the quantityPackage 69238-2782-03. 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 extended-release capsules 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)] . Tacrolimus extended-release capsules 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 ANDA 215012
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 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2780 |
| Tacrolimus | Tacrolimus 1 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2781 |
| tacrolimustacrolimus extended-release capsules | Tacrolimus 1 mg/1 | Capsule, Coated, Extended releaseOral | Chengdu Suncadia Medicine Co., Ltd. | 71432-2002 |
| tacrolimustacrolimus extended-release capsules | Tacrolimus .5 mg/1 | Capsule, Coated, Extended releaseOral | Chengdu Suncadia Medicine Co., Ltd. | 71432-2001 |
| tacrolimustacrolimus extended-release capsules | Tacrolimus 5 mg/1 | Capsule, Coated, Extended releaseOral | Chengdu Suncadia Medicine Co., Ltd. | 71432-2003 |