What is NDC 71610-287?

71610-287 is the product NDC for Spironolactone, Spironolactone 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Spironolactone NDC 71610-287 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-287Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0287Add 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 NDC	11-digit (billing)	Package	Copy
71610-287-30	7161002873071610028730	30 TABLET, FILM COATED in 1 BOTTLE (71610-287-30)Marketed from May 31, 2019
71610-287-45	7161002874571610028745	45 TABLET, FILM COATED in 1 BOTTLE (71610-287-45)Marketed from May 31, 2019

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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203512
Marketing start: Jun 2, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 71610-287_37a5f19e-c2d2-4dde-9aa0-48d70f892e68SPL ID 37a5f19e-c2d2-4dde-9aa0-48d70f892e68SPL set ID f230f1fa-878e-4753-a16c-bf059b59cdefRxCUI 198222, 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

N471610028730 followed by a unit qualifier and the quantity

Package 71610-0287-30. 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 Jun 16, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Spironolactone tablets are indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with: Congestive heart failure: For the management of edema and sodium retention when the patient is…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-287

What is NDC 71610-287?: 71610-287 is the product NDC for Spironolactone, Spironolactone 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4188	68788-4188-0368788-4188-0668788-4188-09
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-0613	67046-0613-03
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	Coupler LLC	67046-0744	67046-0744-03
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-087	48433-0087-20
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-088	48433-0088-20
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-089	48433-0089-08
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1636	67046-1636-03
spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4512	70518-4512-0070518-4512-02
Spironolactone	Spironolactone 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-706	64980-0706-0164980-0706-50
Spironolactone	Spironolactone 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-707	64980-0707-0164980-0707-50

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
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-225
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-226
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-227
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-832
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-835
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-974
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3747
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-344
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3375
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4374
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-146
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-147
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-148
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0053
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0304
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0401
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-288
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-062
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-063