NDC codes

FDA NDC Directory
Product NDC (as listed)70377-014Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0014Add 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 NDC11-digit (billing)PackageCopy
70377-014-117037700141170377001411100 CAPSULE in 1 BOTTLE (70377-014-11)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
Listing expires
Other FDA classes
Calcineurin Inhibitors (Mechanism)
Identifiers
Product ID 70377-014_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

N470377001411 followed by a unit qualifier and the quantity

Package 70377-0014-11. 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 70377-014

What is NDC 70377-014?
70377-014 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TacrolimusTacrolimus .5 mg/1CapsuleOralAvPAK50268-73650268-0736-15
TacrolimusTacrolimus 1 mg/1CapsuleOralAvPAK50268-73750268-0737-15
TacrolimusTacrolimus .5 mg/1CapsuleOralSafecor Health LLC48433-09248433-0092-20
TacrolimusTacrolimus 1 mg/1CapsuleOralSafecor Health LLC48433-09348433-0093-20
TacrolimusTacrolimus 5 mg/1CapsuleOralSafecor Health LLC48433-09448433-0094-20
TacrolimusTacrolimus .5 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-278069238-2780-03
TacrolimusTacrolimus 1 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-278169238-2781-03
TacrolimusTacrolimus 5 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-278269238-2782-03
TacrolimusTacrolimus 5 mg/mLInjectionIntravenousNexus Pharmaceuticals, LLC14789-13514789-0135-05
TacrolimusTacrolimus .5 mg/1CapsuleOralStellon Biotech Inc.85972-10185972-0101-0185972-0101-30

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
ProductStrengthForm · routeLabelerProduct NDC
TacrolimusTacrolimus 1 mg/1CapsuleOralCardinal Health 107, LLC55154-4080
TacrolimusTacrolimus 1 mg/1CapsuleOralBiocon Pharma Inc.70377-015
TacrolimusTacrolimus 5 mg/1CapsuleOralBiocon Pharma Inc.70377-016

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