Spironolactone

Product NDC: 42254-183
11-digit product format: 422540183
Labeler code: 42254
Product ID: 42254-183_c22b0765-1777-4001-836a-2684daf2a35b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA040353
Marketing category: ANDA
Marketing start: 2007-01-03
Marketing end: 0000-00-00
Substance: SPIRONOLACTONE
Active strength: 25 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-183		I	Inactivated by FDA		2026-08-11
excluded package	package	42254-183	42254-183-30	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-183-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-183-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-183-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-183-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-183-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-183-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-183-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-183-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-183-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-183-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-183-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-183-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-183-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-183-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-183-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-183-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-183-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-183-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-183-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-183-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-183-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-183-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040353-001	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29
A040353-002	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29
A040353-003	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040353-002	SPIRONOLACTONE	100MG	TABLET / ORAL	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040353-003	SPIRONOLACTONE	25MG	TABLET / ORAL	2006-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040353-001	SPIRONOLACTONE	50MG	TABLET / ORAL	1999-07-29	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d335cba1-5b36-51c8-120a-594ec9d05330	Product name	5	20251114
25f5e2cf-3572-477b-994c-aa692751e5a8	Product name	2	20250616
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-183-30	2019-09-24	C162847	48780-1	9350213a-3d91-c013-e053-90daa90a1393	SPIRONOLACTONE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-183-30	Spironolactone	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-183-30	EA - Each	42254-183	f049f77f-5057-44cf-8ed1-67fd29f00fd5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-183	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120511_c22b0765-1777-4001-836a-2684daf2a35b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
27O7W4T232	SPIRONOLACTONE	52-01-7	SPIRONOLACTONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313096	spironolactone 25 MG Oral Tablet	PSN	c22b0765-1777-4001-836a-2684daf2a35b	1
313096	spironolactone 25 MG Oral Tablet	SCD	c22b0765-1777-4001-836a-2684daf2a35b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-183-30	42254018330	30 in 1 BOTTLE	Historical