NDC codes

FDA NDC Directory
Product NDC (as listed)72789-291Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0291Add 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
72789-291-30727890291307278902913030 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-30)Marketed from Dec 12, 2022
72789-291-60727890291607278902916060 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-60)Marketed from Dec 12, 2022
72789-291-827278902918272789029182500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-82)Marketed from Dec 12, 2022
72789-291-90727890291907278902919090 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-90)Marketed from Dec 12, 2022

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 — 50 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040750
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 72789-291_56d3337e-6bff-034a-e063-6294a90a7af4SPL ID 56d3337e-6bff-034a-e063-6294a90a7af4SPL set ID 8a66d90e-5450-4716-8c01-e7dc1967d00dRxCUI 198223UNII 27O7W4T232UPC 0372789291307
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

N472789029130 followed by a unit qualifier and the quantity

Package 72789-0291-30. 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 .

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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72789-291

What is NDC 72789-291?
72789-291 is the product NDC for Spironolactone, Spironolactone 50 mg/1 tablet, coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 040750

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

FDA NDC Directory listings under ANDA 040750
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralA-S Medication Solutions50090-6369
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralA-S Medication Solutions50090-6458
SpironolactoneSpironolactone 100 mg/1Tablet, CoatedOralA-S Medication Solutions50090-6539
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralA-S Medication Solutions50090-6600
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7797
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralAphena Pharma Solutions - Tennessee, LLC53401-041
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralCoupler LLC67046-0613
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralCoupler LLC67046-0744
SpironolactoneSpironolactone 100 mg/1Tablet, CoatedOralCoupler LLC67046-1636
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralNuCare Pharmaceuticals, Inc.68071-3967
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralNuCare Pharmaceuticals,Inc.68071-3969
SpironolactoneSpironolactone 100 mg/1Tablet, CoatedOralPreferred Pharmaceuticals, Inc68788-8381
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-8452
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-8545
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralOxford Pharmaceuticals, LLC69584-852
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralOxford Pharmaceuticals, LLC69584-853
SpironolactoneSpironolactone 100 mg/1Tablet, CoatedOralOxford Pharmaceuticals, LLC69584-854
SpironolactoneSpironolactone 25 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-3625
SpironolactoneSpironolactone 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-3655
SpironolactoneSpironolactone 100 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-3721

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