NDC codes

FDA NDC Directory
Product NDC (as listed)55154-4168Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-4168Add 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
55154-4168-0551544168005515441680010 BLISTER PACK in 1 BAG (55154-4168-0) / 1 CAPSULE in 1 BLISTER PACKMarketed from Aug 13, 2014

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 — 1 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090687
Marketing start
Listing expires
Other FDA classes
Calcineurin Inhibitors (Mechanism)
Identifiers
Product ID 55154-4168_6ee05111-8467-41c9-857f-5a805ce7490bSPL ID 6ee05111-8467-41c9-857f-5a805ce7490b
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

N455154416800 followed by a unit qualifier and the quantity

Package 55154-4168-00. 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 55154-4168

What is NDC 55154-4168?
55154-4168 is the product NDC for Tacrolimus, Tacrolimus 1 mg/1 capsule, listed with the FDA by Cardinal Health 107, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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 090687

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

FDA NDC Directory listings under ANDA 090687
ProductStrengthForm · routeLabelerProduct NDC
TacrolimusTacrolimus 1 mg/1CapsuleOralMajor Pharmaceuticals0904-7097
TacrolimusTacrolimus .5 mg/1CapsuleOralStrides Pharma Science Limited64380-720
TacrolimusTacrolimus 1 mg/1CapsuleOralStrides Pharma Science Limited64380-721
TacrolimusTacrolimus 5 mg/1CapsuleOralStrides Pharma Science Limited64380-722

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