spironolactone

Product NDC: 68382-661
11-digit product format: 683820661
Labeler code: 68382
Product ID: 68382-661_79b8df9c-5a73-432e-bd16-bbbecd9e2046
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA205936
Marketing category: ANDA
Marketing start: 2018-08-15
Substance: SPIRONOLACTONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	TE codes	Approval date
A205936-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18
A205936-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18
A205936-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205936-001	AB
A205936-002	AB
A205936-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205936-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: spironolactone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
27O7W4T232	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198222	Internal RxNorm lookup
198223	Internal RxNorm lookup
313096	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
99bbc053-0e41-4b4d-979a-db610908f2de	Available on FDA.report

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
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-661-01	spironolactone	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
68382-661-05	spironolactone	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
68382-661-06	spironolactone	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
68382-661-10	spironolactone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
68382-661-16	spironolactone	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
68382-661-30	spironolactone	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	8
68382-661-30	spironolactone	10 in 1 CARTON	TABLET, FILM COATED	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-661-01	EA - Each	68382-661	dc32173b-ce2a-41ac-b8c7-0a0b702dc0b3	1	2018-12-13
68382-661-05	EA - Each	68382-661	a2aa7e3c-8351-42b1-a885-802a98d14420	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-661	SPIRONOLACTONE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	6	Current NDC, Legacy NDC, 7 package rows	20230919_99bbc053-0e41-4b4d-979a-db610908f2de.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	8b76a904-6c99-485a-a05f-13a36c5f720c	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Cardinal Health 107, LLC	96db5dee-7c01-4f96-8b1e-1fcd2103d0fe	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f988aa11-60ed-411e-e053-6294a90a522a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f32e8109-73e1-a249-e053-2995a90a3fae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	eb27a2d2-1d28-4780-8e69-5fe613a0335e	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Major Pharmaceuticals	0c45d793-6f2f-4622-b5ed-6875acfbc02b	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Zydus Lifesciences Limited	963af399-feb7-49d2-a59c-c19edad9c682	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Zydus Pharmaceuticals (USA) Inc.	99bbc053-0e41-4b4d-979a-db610908f2de	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936 ndc (product): 68382-661
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	39d82d50-0b77-4ef5-96b8-c1e05044a82c	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
Spironolactone	SPIRONOLACTONE	American Health Packaging	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	2024-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936

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
198222	spironolactone 100 MG Oral Tablet	PSN	99bbc053-0e41-4b4d-979a-db610908f2de	8
313096	spironolactone 25 MG Oral Tablet	PSN	99bbc053-0e41-4b4d-979a-db610908f2de	8
198223	spironolactone 50 MG Oral Tablet	PSN	99bbc053-0e41-4b4d-979a-db610908f2de	8
198222	spironolactone 100 MG Oral Tablet	SCD	99bbc053-0e41-4b4d-979a-db610908f2de	8
313096	spironolactone 25 MG Oral Tablet	SCD	99bbc053-0e41-4b4d-979a-db610908f2de	8
198223	spironolactone 50 MG Oral Tablet	SCD	99bbc053-0e41-4b4d-979a-db610908f2de	8
198222	spironolactone 100 MG Oral Tablet	PSN	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	5
313096	spironolactone 25 MG Oral Tablet	PSN	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	5
198223	spironolactone 50 MG Oral Tablet	PSN	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	5
198222	spironolactone 100 MG Oral Tablet	SCD	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	5
313096	spironolactone 25 MG Oral Tablet	SCD	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	5
198223	spironolactone 50 MG Oral Tablet	SCD	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	5
198223	spironolactone 50 MG Oral Tablet	PSN	eb27a2d2-1d28-4780-8e69-5fe613a0335e	3
198223	spironolactone 50 MG Oral Tablet	SCD	eb27a2d2-1d28-4780-8e69-5fe613a0335e	3
198223	spironolactone 50 MG Oral Tablet	PSN	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2
198223	spironolactone 50 MG Oral Tablet	SCD	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-661-01	68382066101	100 TABLET, FILM COATED in 1 BOTTLE (68382-661-01)		2018-08-15	0000-00-00	No	No	Current
68382-661-05	68382066105	500 TABLET, FILM COATED in 1 BOTTLE (68382-661-05)		2018-08-15	0000-00-00	No	No	Current
68382-661-06	68382066106	30 TABLET, FILM COATED in 1 BOTTLE (68382-661-06)		2018-08-15	0000-00-00	No	No	Current
68382-661-10	68382066110	1000 TABLET, FILM COATED in 1 BOTTLE (68382-661-10)		2018-08-15	0000-00-00	No	No	Current
68382-661-16	68382066116	90 TABLET, FILM COATED in 1 BOTTLE (68382-661-16)		2018-08-15	0000-00-00	No	No	Current
68382-661-30	68382066130	10 BLISTER PACK in 1 CARTON (68382-661-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2018-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
spironolactone	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
spironolactone	REMEDYREPACK INC.	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	3
spironolactone	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Limited	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	8
spironolactone	REMEDYREPACK INC.	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	12
spironolactone	REMEDYREPACK INC.	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	9
spironolactone	Quality Care Products, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
Spironolactone	American Health Packaging	2024-10-17	HUMAN PRESCRIPTION DRUG LABEL	5
spironolactone	Bryant Ranch Prepack	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL	6