NDC codes

FDA NDC Directory
Product NDC (as listed)55154-5517Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-5517Add 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
55154-5517-05515455170010 BLISTER PACK in 1 BAG (55154-5517-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 4, 2011

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)
Spironolactone
Generic name (nonproprietary)
spironolactone
Active ingredients
Spironolactone — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040424
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 55154-5517_c82eaedf-5562-415f-9df4-c88bc9545088SPL ID c82eaedf-5562-415f-9df4-c88bc9545088SPL set ID 48115c9e-c82f-438d-b178-dce1b73687dbRxCUI 313096UNII 27O7W4T232UPC 0055154551700
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

N455154551700 followed by a unit qualifier and the quantity

Package 55154-5517-00. 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 tablets are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040424

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

FDA NDC Directory listings under ANDA 040424
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralSafecor Health LLC48433-089
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralSafecor Health LLC48433-087
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralSafecor Health LLC48433-088
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC67544-310
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2150
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-979
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-980
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-0243
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-0437
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-2146
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-103

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