Prescription drug · ANDA

spironolactone NDC 68382-662

Spironolactone 100 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals (USA) Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68382-662Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0662Add 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
68382-662-0168382066201100 TABLET, FILM COATED in 1 BOTTLE (68382-662-01)Marketed from Aug 15, 2018
68382-662-0568382066205500 TABLET, FILM COATED in 1 BOTTLE (68382-662-05)Marketed from Aug 15, 2018
68382-662-066838206620630 TABLET, FILM COATED in 1 BOTTLE (68382-662-06)Marketed from Aug 15, 2018
68382-662-10683820662101000 TABLET, FILM COATED in 1 BOTTLE (68382-662-10)Marketed from Aug 15, 2018
68382-662-166838206621690 TABLET, FILM COATED in 1 BOTTLE (68382-662-16)Marketed from Aug 15, 2018
68382-662-306838206623010 BLISTER PACK in 1 CARTON (68382-662-30) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 15, 2018

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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205936
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 68382-662_79b8df9c-5a73-432e-bd16-bbbecd9e2046SPL ID 79b8df9c-5a73-432e-bd16-bbbecd9e2046SPL set ID 99bbc053-0e41-4b4d-979a-db610908f2deRxCUI 198222, 198223, 313096UNII 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

N468382066201 followed by a unit qualifier and the quantity

Package 68382-0662-01. 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 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)

Other NDCs under ANDA 205936

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

FDA NDC Directory listings under ANDA 205936
ProductStrengthForm · routeLabelerProduct NDC
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-861
spironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1029
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1027
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1028
SpironolactoneSpironolactone 50 mg/1TabletOralAmerican Health Packaging60687-476
SpironolactoneSpironolactone 100 mg/1TabletOralAmerican Health Packaging60687-487
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4468
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3556
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4470
spironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4512
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralZydus Pharmaceuticals (USA) Inc.68382-660
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralZydus Pharmaceuticals (USA) Inc.68382-661
spironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-153
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-636
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6927
SpironolactoneSpironolactone 25 mg/1TabletOralAmerican Health Packaging60687-465

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