NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3903Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3903Add the package segment from the table below.

Product information

Brand name (proprietary)
Spironolactone
Generic name (nonproprietary)
spironolactone
Active ingredients
Spironolactone — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
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 68071-3903_4239ca20-57c9-02b2-e063-6294a90a72f1SPL ID 4239ca20-57c9-02b2-e063-6294a90a72f1SPL set ID 4239da9e-dd0c-9af0-e063-6394a90a3cbbRxCUI 198222UNII 27O7W4T232UPC 0368071390391
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.

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1) . Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2) . The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sod…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3903

What is NDC 68071-3903?
68071-3903 is the product NDC for Spironolactone, Spironolactone 100 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc..
What drug is associated with this NDC?
Spironolactone.
What is the active ingredient?
Spironolactone.
Who is the labeler?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 100 mg/1TabletOralAurobindo Pharma Limited59651-428
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/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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