NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0304Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0304Add 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
71335-0304-17133503040171335030401100 TABLET, FILM COATED in 1 BOTTLE (71335-0304-1)Marketed from Feb 9, 2022
71335-0304-271335030402713350304023 TABLET, FILM COATED in 1 BOTTLE (71335-0304-2)Marketed from Feb 9, 2022
71335-0304-3713350304037133503040330 TABLET, FILM COATED in 1 BOTTLE (71335-0304-3)Marketed from Feb 9, 2022
71335-0304-4713350304047133503040490 TABLET, FILM COATED in 1 BOTTLE (71335-0304-4)Marketed from Feb 9, 2022
71335-0304-5713350304057133503040560 TABLET, FILM COATED in 1 BOTTLE (71335-0304-5)Marketed from Feb 9, 2022

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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203512
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 71335-0304_542e0c25-81f4-41bb-a88b-f2a433227739SPL ID 542e0c25-81f4-41bb-a88b-f2a433227739SPL set ID 2ed347bc-a9f1-4800-99bc-9af9912ead1fRxCUI 198222UNII 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

N471335030401 followed by a unit qualifier and the quantity

Package 71335-0304-01. 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)

About NDC 71335-0304

What is NDC 71335-0304?
71335-0304 is the product NDC for Spironolactone, Spironolactone 100 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 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 71335. 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 203512

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

FDA NDC Directory listings under ANDA 203512
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-225
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-226
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-227
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-832
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-835
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-974
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3747
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-344
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3375
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4374
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralProficient Rx LP71205-146
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-147
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralProficient Rx LP71205-148
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0053
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0401
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-287
SpironolactoneSpironolactone 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-288
SpironolactoneSpironolactone 25 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-062
SpironolactoneSpironolactone 50 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-063

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