Viewing data from:

SPIRONOLACTONE

ANDA

SPIRONOLACTONE | A040424 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ALDACTONE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs

Highest NADAC/Unit

$0.1759

per ea

Lowest NADAC/Unit

$0.0443

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51079098008SPIRONOLACTONE 100 MG TABLET	$0.1759	EA	Generic	—	2026-06-17
00378043701SPIRONOLACTONE 100 MG TABLET	$0.1759	EA	Generic	—	2026-06-17
00378024301SPIRONOLACTONE 50 MG TABLET	$0.0875	EA	Generic	—	2026-06-17
00378024305SPIRONOLACTONE 50 MG TABLET	$0.0875	EA	Generic	—	2026-06-17
51079097920SPIRONOLACTONE 50 MG TABLET	$0.0875	EA	Generic	—	2026-06-17
51079010320SPIRONOLACTONE 25 MG TABLET	$0.0443	EA	Generic	—	2026-06-17
00378214605SPIRONOLACTONE 25 MG TABLET	$0.0443	EA	Generic	—	2026-06-17
00378214601SPIRONOLACTONE 25 MG TABLET	$0.0443	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 7 NDCs (7 FSS)

Lowest Price

$4.88

Highest Price

$101.45

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00378-2146-01SPIRONOLACTONE 25MG TAB	$4.88	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-2146-05SPIRONOLACTONE 25MG TAB	$25.27	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
51079-0979-20SPIRONOLACTONE 50MG TAB 10X10	$28.77	FSS	Mylan Institutional, Inc.	09/29/2026
00378-0437-01SPIRONOLACTONE 100MG TAB	$13.92	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-0243-01SPIRONOLACTONE 50MG TAB	$20.29	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-0243-05SPIRONOLACTONE 50MG TAB	$101.45	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
51079-0103-20SPIRONOLACTONE 25MG TAB	$10.27	FSS	Mylan Institutional, Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain9 active DMFs9 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

GEDEON RICHTER PLCSPIRONOLACTONE USP

DMF 140771999

EUROAPI FRANCESPIRONOLACTONE

DMF 172642004

TIANJIN TIANYAO PHARMACEUTICALS CO LTDSPIRONOLACTONE USP BULK

DMF 182382005

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDSPIRONOLACTONE

DMF 202862007

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDSPIRONOLACTONE

DMF 268812013

TIANJIN JINJIN PHARMACEUTICAL CO LTDSPIRONOLACTONE USP BULK API

DMF 301922015

HUBEI GOTO BIOTECHNOLOGY CO LTDSPIRONOLACTONE

DMF 323702018

DASAMI LAB PRIVATE LTDSPIRONOLACTONE USP

DMF 366782022

NORTEC QUIMICA SASPIRONOLACTONE

DMF 377082024

ANTIBIOTICOS SPAInactiveSPIRONOLACTONE

DMF 26571976

DIPHARMA FRANCIS SRLInactiveSPIRONOLACTONE

DMF 30521977

SCHERING AGInactiveSPIRONOLACTONE

DMF 33321978

MEDIMPEX NORTHAMERICA INCInactiveSPIRONOLACTONE USP XIX

DMF 33431978

BOEHRINGER MANNHEIM GMBHInactiveSPIRONOLACTONE (BULK FORM) USP XIX, BP 1973

DMF 33501978

DIOSYNTH BVInactiveSPIRONOLACTONE MICRO

DMF 37181980

OLON SPAInactiveSPIRONOLACTONE

DMF 185462005

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveSPIRONOLACTONE

DMF 198592006

PIRAMAL HEALTHCARE UK LTDInactiveSPIRONOLACTONE USP

DMF 254962012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 20, 2001

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 20, 2001

#003 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 20, 2001