NDC codes

FDA NDC Directory
Product NDC (as listed)63629-1067Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-1067Add 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
63629-1067-1636291067016362910670130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-1)Marketed from Sep 21, 2020
63629-1067-2636291067026362910670260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-2)Marketed from Dec 1, 2020
63629-1067-3636291067036362910670390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-3)Marketed from Dec 14, 2020
63629-1067-46362910670463629106704500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-4)Marketed from Dec 14, 2020

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 089424
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 63629-1067_00dbe2f7-5d25-493a-8d78-6b7ee0e6ab2bSPL ID 00dbe2f7-5d25-493a-8d78-6b7ee0e6ab2bSPL set ID 3b60de71-2afa-4922-ba3e-0664c2ae29a0RxCUI 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

N463629106701 followed by a unit qualifier and the quantity

Package 63629-1067-01. 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 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 fl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1067

What is NDC 63629-1067?
63629-1067 is the product NDC for Spironolactone, Spironolactone 50 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
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 089424

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

FDA NDC Directory listings under ANDA 089424
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack71335-2301
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6408
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4188
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6432
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1065
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1626
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack63629-1061
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack72162-1624
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack63629-1062
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack63629-1064
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1627
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1066
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-830
SpironolactoneSpironolactone 25 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-970
SpironolactoneSpironolactone 25 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-742
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack71335-2846
SpironolactoneSpironolactone 25 mg/1TabletOralSun Pharmaceutical Industries, Inc.53489-143
SpironolactoneSpironolactone 25 mg/1TabletOralBryant Ranch Prepack63629-8539
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.53489-328
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.53489-329

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