NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2189Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2189Add 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
71335-2189-1713352189017133521890160 CAPSULE in 1 BOTTLE (71335-2189-1)Marketed from Nov 3, 2022

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
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091195
Marketing start
Listing expires
Other FDA classes
Calcineurin Inhibitors (Mechanism)
Identifiers
Product ID 71335-2189_bcd0e46a-cabb-4a0d-81c8-f41368a3bd74SPL ID bcd0e46a-cabb-4a0d-81c8-f41368a3bd74SPL set ID a2e55495-10cc-4f6e-b866-1e7d6e45888bRxCUI 313190UNII 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

N471335218901 followed by a unit qualifier and the quantity

Package 71335-2189-01. 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 is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1) ] , liver transplant [see Clinical Studies (14.2) ], or heart transplant [see Clinical Studies (14.3) ] and pediatric patients receiving allogeneic liver transplants [see…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2189

What is NDC 71335-2189?
71335-2189 is the product NDC for Tacrolimus, Tacrolimus .5 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 091195

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

FDA NDC Directory listings under ANDA 091195
ProductStrengthForm · routeLabelerProduct NDC
TacrolimusTacrolimus .5 mg/1CapsuleOralAccord Healthcare Inc.16729-041
TacrolimusTacrolimus 1 mg/1CapsuleOralAccord Healthcare Inc.16729-042
TacrolimusTacrolimus 5 mg/1CapsuleOralAccord Healthcare Inc.16729-043
TacrolimusTacrolimus 1 mg/1CapsuleOralBryant Ranch Prepack63629-9325

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