What is NDC 70377-016?

70377-016 is the product NDC for Tacrolimus, Tacrolimus 5 mg/1 capsule, listed with the FDA by Biocon Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Biocon Pharma Inc., NDC labeler code 70377. 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 70377-016 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70377-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70377-0016Add 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
70377-016-11	7037700161170377001611	100 CAPSULE in 1 BOTTLE (70377-016-11)Marketed from Dec 23, 2020

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 — 5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Biocon Pharma Inc.NDC labeler code 70377
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212297
Marketing start: Dec 23, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 70377-016_05f1f8c4-a781-7d60-4856-c23349ef1958SPL ID 05f1f8c4-a781-7d60-4856-c23349ef1958
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

N470377001611 followed by a unit qualifier and the quantity

Package 70377-0016-11. 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 70377-016

What is NDC 70377-016?: 70377-016 is the product NDC for Tacrolimus, Tacrolimus 5 mg/1 capsule, listed with the FDA by Biocon Pharma 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?: Biocon Pharma Inc., NDC labeler code 70377. 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 212297

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

FDA NDC Directory listings under ANDA 212297
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-4080
Tacrolimus	Tacrolimus .5 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-014
Tacrolimus	Tacrolimus 1 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-015