NDC codes

FDA NDC Directory
Product NDC (as listed)48433-094Labeler and product segments. Claims need a package NDC.
Product NDC at billing width48433-0094Add 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
48433-094-204843300942048433009420100 BLISTER PACK in 1 CARTON (48433-094-20) / 1 CAPSULE in 1 BLISTER PACK (48433-094-01)Marketed from Mar 13, 2026

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
Safecor Health LLCNDC labeler code 48433
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090596
Marketing start
Listing expires
Other FDA classes
Calcineurin Inhibitors (Mechanism)
Identifiers
Product ID 48433-094_4ee47a06-cf78-3bca-e063-6394a90ad20aSPL ID 4ee47a06-cf78-3bca-e063-6394a90ad20aSPL set ID 393cd10e-133c-4d6b-b024-270eb82edbb3RxCUI 198377, 198378, 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

N448433009420 followed by a unit qualifier and the quantity

Package 48433-0094-20. 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 capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart 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 and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies (14.1) ] , liver transplant [see Clinical Studies (14.2) ] , and heart transplant [see Clinical Studies (14.3) ] , in combination with other immunosuppressants. Additional pediatric use information is …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 48433-094

What is NDC 48433-094?
48433-094 is the product NDC for Tacrolimus, Tacrolimus 5 mg/1 capsule, listed with the FDA by Safecor Health 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?
Safecor Health LLC, NDC labeler code 48433. 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/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
TacrolimusTacrolimus 1 mg/1CapsuleOralStellon Biotech Inc.85972-10285972-0102-0185972-0102-30

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
ProductStrengthForm · routeLabelerProduct NDC
TacrolimusTacrolimus .5 mg/1CapsuleOralMylan Pharmaceuticals Inc.0378-2045
TacrolimusTacrolimus 1 mg/1CapsuleOralMylan Pharmaceuticals Inc.0378-2046
TacrolimusTacrolimus 5 mg/1CapsuleOralMylan Pharmaceuticals Inc.0378-2047
TacrolimusTacrolimus 1 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC43353-317
TacrolimusTacrolimus .5 mg/1CapsuleOralSafecor Health LLC48433-092
TacrolimusTacrolimus 1 mg/1CapsuleOralSafecor Health LLC48433-093
TacrolimusTacrolimus 5 mg/1CapsuleOralMylanInstitutional Inc.51079-028
TacrolimusTacrolimus .5 mg/1CapsuleOralMylanInstitutional Inc.51079-817
TacrolimusTacrolimus 1 mg/1CapsuleOralMylanInstitutional Inc.51079-818
TacrolimusTacrolimus .5 mg/1CapsuleOralGolden State Medical Supply, Inc.60429-377
TacrolimusTacrolimus 1 mg/1CapsuleOralGolden State Medical Supply, Inc.60429-378
TacrolimusTacrolimus 5 mg/1CapsuleOralGolden State Medical Supply, Inc.60429-379

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in