Prescription drug · ANDA

spironolactone NDC 70771-1029

Spironolactone 100 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1029Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1029Add 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
70771-1029-070771102900707711029001000 TABLET, FILM COATED in 1 BOTTLE (70771-1029-0)Marketed from Aug 15, 2018
70771-1029-17077110290170771102901100 TABLET, FILM COATED in 1 BOTTLE (70771-1029-1)Marketed from Aug 15, 2018
70771-1029-3707711029037077110290330 TABLET, FILM COATED in 1 BOTTLE (70771-1029-3)Marketed from Aug 15, 2018
70771-1029-4707711029047077110290410 BLISTER PACK in 1 CARTON (70771-1029-4) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 15, 2018
70771-1029-57077110290570771102905500 TABLET, FILM COATED in 1 BOTTLE (70771-1029-5)Marketed from Aug 15, 2018
70771-1029-9707711029097077110290990 TABLET, FILM COATED in 1 BOTTLE (70771-1029-9)Marketed from Aug 15, 2018

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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
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 70771-1029_038310cc-d190-4868-9442-00f7222d0597SPL ID 038310cc-d190-4868-9442-00f7222d0597SPL set ID 963af399-feb7-49d2-a59c-c19edad9c682RxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0370771102716
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

N470771102900 followed by a unit qualifier and the quantity

Package 70771-1029-00. 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 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 70771-1029

What is NDC 70771-1029?
70771-1029 is the product NDC for spironolactone, Spironolactone 100 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 6 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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 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 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6927
spironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-153
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-636
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-861
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3556
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-465
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-476
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-487
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 coatedOralZydus Pharmaceuticals (USA) Inc.68382-662
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4468
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4470
spironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4512
spironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1027
spironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1028

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