What is NDC 43353-317?

43353-317 is the product NDC for Tacrolimus, Tacrolimus 1 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tacrolimus NDC 43353-317 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-317Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0317Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43353-317-09	4335303170943353031709	9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09)Marketed from May 3, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 1 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090596
Marketing start: Nov 18, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 43353-317_815744b6-6096-4a89-8171-cdca95e10631SPL ID 815744b6-6096-4a89-8171-cdca95e10631SPL set ID 4caa20af-45a8-4365-9f06-1568afae61b1RxCUI 198377UNII WM0HAQ4WNM
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

N443353031709 followed by a unit qualifier and the quantity

Package 43353-0317-09. 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 May 3, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

Tacrolimus capsules, USP are a calcineurin-inhibitor immunosuppressant indicated for: • Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants ( 1.1 , 1.2 , 1.3 ) • Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) ( 1.1 , 1.2 , 1.3 ) • Limitations of Use ( 1.4 ): • Do not use simultaneously with cyclosporine • Intravenous use reserved for patients who cannot tolerate capsules orally • Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established 1.1 Prophylaxis of Organ Rejection …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-317

What is NDC 43353-317?: 43353-317 is the product NDC for Tacrolimus, Tacrolimus 1 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tacrolimus NDCs
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

All 94 Tacrolimus NDCs

Other NDCs under ANDA 090596

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090596
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-2045
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	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.	51079-028
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	MylanInstitutional Inc.	51079-817
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	MylanInstitutional Inc.	51079-818
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