Spironolactone

Product NDC: 59746-218
11-digit product format: 597460218
Labeler code: 59746
Product ID: 59746-218_7839b797-5078-4aab-93a5-6056e4b9cdd5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Jubilant Cadista Pharmacuticals Inc.
Application: ANDA203253
Marketing category: ANDA
Marketing start: 2013-02-01
Substance: SPIRONOLACTONE
Active strength: 100 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
A203253-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23
A203253-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23
A203253-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203253-001	AB
A203253-002	AB
A203253-003	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	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203253-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-04-23	`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	A203253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203253-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203253-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203253-001	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	100 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
a7510768-8a52-4230-6aa0-b0d92d82588f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59746-218-01	2023-05-08	These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960
59746-218-05	2023-05-08	These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960
59746-218-01	2023-01-30	These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960
59746-218-05	2023-01-30	These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59746-218-01	Spironolactone	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
59746-218-05	Spironolactone	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
59746-218-06	Spironolactone	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
59746-218-09	Spironolactone	500 in 1 BOTTLE	TABLET, FILM COATED	500	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-218-01	EA - Each	59746-218	9a240689-1863-4869-8925-3d86f8212ba5	1	2015-01-05
59746-218-06	EA - Each	59746-218	c906914d-1d4d-4997-9d10-13fb3e93b208	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
spironolactone	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
spironolactone	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
calcium sulfate	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Calcium Sulfate Dihydrate	INACTIVE INGREDIENT	4846Q921YM	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Peppermint	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
povidone	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-218	SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240728_a7510768-8a52-4230-6aa0-b0d92d82588f.zip
59746-218	SPIRONOLACTONE TABLET, FILM COATED SPIRONOLACTONE TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20240810_c1c5fdab-3ff7-414b-8e25-beed8311b8ad.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	6518ba72-89e4-4f2f-b334-9ef759b696f8	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	QPharma, Inc.	37066684-5b63-4d3e-ae6a-08c4b3edd7aa	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	37b9bc61-2757-454a-935b-752d13eb7eb4	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	b5b129b8-aed9-4d94-a35e-e92647effbdb	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	574efac6-b2d9-4053-940c-552f01a69b2e	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 59746-218
Spironolactone	SPIRONOLACTONE	Jubilant Cadista Pharmacuticals Inc.	a7510768-8a52-4230-6aa0-b0d92d82588f	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253 ndc (product): 59746-218
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	5c2ae130-8e84-4c3f-b190-82691312fcbd	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	caf9c845-63eb-40bd-8261-0582abdf705a	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203253 application number: ANDA203253

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	a7510768-8a52-4230-6aa0-b0d92d82588f	8
313096	spironolactone 25 MG Oral Tablet	PSN	a7510768-8a52-4230-6aa0-b0d92d82588f	8
198223	spironolactone 50 MG Oral Tablet	PSN	a7510768-8a52-4230-6aa0-b0d92d82588f	8
198222	spironolactone 100 MG Oral Tablet	SCD	a7510768-8a52-4230-6aa0-b0d92d82588f	8
313096	spironolactone 25 MG Oral Tablet	SCD	a7510768-8a52-4230-6aa0-b0d92d82588f	8
198223	spironolactone 50 MG Oral Tablet	SCD	a7510768-8a52-4230-6aa0-b0d92d82588f	8
198222	spironolactone 100 MG Oral Tablet	PSN	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	1
313096	spironolactone 25 MG Oral Tablet	PSN	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	1
198223	spironolactone 50 MG Oral Tablet	PSN	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	1
198222	spironolactone 100 MG Oral Tablet	SCD	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	1
313096	spironolactone 25 MG Oral Tablet	SCD	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	1
198223	spironolactone 50 MG Oral Tablet	SCD	c1c5fdab-3ff7-414b-8e25-beed8311b8ad	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-218-01	59746021801	100 TABLET, FILM COATED in 1 BOTTLE (59746-218-01)	2017-04-04	0000-00-00	No	No	Current
59746-218-05	59746021805	500 TABLET, FILM COATED in 1 BOTTLE (59746-218-05)	2017-04-04	0000-00-00	No	No	Current
59746-218-06	59746021806	100 TABLET, FILM COATED in 1 BOTTLE (59746-218-06)	2017-04-04		No	No	Current
59746-218-09	59746021809	500 TABLET, FILM COATED in 1 BOTTLE (59746-218-09)	2017-04-04		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone	REMEDYREPACK INC.	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	6
Spironolactone	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	103
Spironolactone	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Generics Limited	2024-08-01	Human Prescription Drug Label	1
Spironolactone	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Generics Limited	2024-07-17	Human Prescription Drug Label	8
Spironolactone	Preferred Pharmaceuticals Inc.	2019-05-01	HUMAN PRESCRIPTION DRUG LABEL	2