NDC codes

FDA NDC Directory
Product NDC (as listed)59651-428Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0428Add 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
59651-428-015965104280159651042801100 TABLET in 1 BOTTLE (59651-428-01)Marketed from Dec 13, 2019
59651-428-055965104280559651042805500 TABLET in 1 BOTTLE (59651-428-05)Marketed from Aug 24, 2023

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)
Spironolactone
Generic name (nonproprietary)
spironolactone
Active ingredients
Spironolactone — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202187
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 59651-428_81936486-134f-439a-aa35-99fe0afdc9c5SPL ID 81936486-134f-439a-aa35-99fe0afdc9c5
Pharmacologic class
Aldosterone Antagonist

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

N459651042801 followed by a unit qualifier and the quantity

Package 59651-0428-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 59651-428

What is NDC 59651-428?
59651-428 is the product NDC for Spironolactone, Spironolactone 100 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Spironolactone.
What is the active ingredient?
Spironolactone.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Spironolactone?
177 other product NDCs are listed under this name. See all Spironolactone 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 Spironolactone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-418868788-4188-0368788-4188-0668788-4188-09
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralCoupler LLC67046-061367046-0613-03
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralCoupler LLC67046-074467046-0744-03
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralSafecor Health LLC48433-08748433-0087-20
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralSafecor Health LLC48433-08848433-0088-20
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralSafecor Health LLC48433-08948433-0089-08
SpironolactoneSpironolactone 100 mg/1Tablet, CoatedOralCoupler LLC67046-163667046-1636-03
spironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-451270518-4512-0070518-4512-02
SpironolactoneSpironolactone 25 mg/1TabletOralRising Pharma Holdings, Inc.64980-70664980-0706-0164980-0706-50
SpironolactoneSpironolactone 50 mg/1TabletOralRising Pharma Holdings, Inc.64980-70764980-0707-0164980-0707-50

All 178 Spironolactone NDCs

Other NDCs under ANDA 202187

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

FDA NDC Directory listings under ANDA 202187
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 25 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8451
SpironolactoneSpironolactone 50 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8452
SpironolactoneSpironolactone 25 mg/1TabletOralA-S Medication Solutions50090-6908
SpironolactoneSpironolactone 25 mg/1TabletOralA-S Medication Solutions50090-6909
SpironolactoneSpironolactone 50 mg/1TabletOralA-S Medication Solutions50090-7082
SpironolactoneSpironolactone 50 mg/1TabletOralA-S Medication Solutions50090-7083
SpironolactoneSpironolactone 25 mg/1TabletOralAurobindo Pharma Limited59651-426
SpironolactoneSpironolactone 50 mg/1TabletOralAurobindo Pharma Limited59651-427
SpironolactoneSpironolactone 50 mg/1TabletOralRedpharm Drug67296-2285
SpironolactoneSpironolactone 25 mg/1TabletOralRedpharm Drug67296-2319
SpironolactoneSpironolactone 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2988
SpironolactoneSpironolactone 25 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2989
SpironolactoneSpironolactone 50 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3795
SpironolactoneSpironolactone 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3903
SpironolactoneSpironolactone 100 mg/1TabletOralREMEDYREPACK INC.70518-4447
SpironolactoneSpironolactone 100 mg/1TabletOralBryant Ranch Prepack72162-2681
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack72162-2682
SpironolactoneSpironolactone 50 mg/1TabletOralBryant Ranch Prepack72162-2683
SpironolactoneSpironolactone 25 mg/1TabletOralNorthStar Rx LLC72603-134
SpironolactoneSpironolactone 50 mg/1TabletOralNorthStar Rx LLC72603-135

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