NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2438Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2438Add 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
63629-2438-16362924380163629243801100 TABLET, FILM COATED in 1 BOTTLE (63629-2438-1)Marketed from Apr 4, 2017

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 — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203253
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 63629-2438_dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1deSPL ID dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1deSPL set ID 9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1RxCUI 198223UNII 27O7W4T232
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

N463629243801 followed by a unit qualifier and the quantity

Package 63629-2438-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Spironolactone tablets are 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 63629-2438

What is NDC 63629-2438?
63629-2438 is the product NDC for Spironolactone, Spironolactone 50 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 203253

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

FDA NDC Directory listings under ANDA 203253
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralQPharma, Inc.42708-101
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralJubilant Cadista Pharmacuticals Inc.59746-216
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralJubilant Cadista Pharmacuticals Inc.59746-217
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralJubilant Cadista Pharmacuticals Inc.59746-218
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-841
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-861
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2437
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0665
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1693
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1694

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