SPIRONOLACTONE

Product NDC: 16714-086
Requested package NDC: 16714-086-02
11-digit product format: 167140086
Labeler code: 16714
Product ID: 16714-086_192faced-01bc-42a8-ad1f-492d6c3108f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SPIRONOLACTONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA089424
Marketing category: ANDA
Marketing start: 2020-04-23
Marketing end: 0000-00-00
Substance: SPIRONOLACTONE
Active strength: 100 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-086	16714-086-02	D	Discontinued by firm		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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A089424-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23
A089424-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11
A089424-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089424-001	AB
A089424-002	AB
A089424-003	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	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`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	A089424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089424-001	AB	1	`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
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-086-01	EA - Each	16714-086	bb41d7f8-2c0a-4522-8afb-027c9e5d556f	1	2020-09-14
16714-086-02	EA - Each	16714-086	16453476-8683-46ea-a02c-5796e905638c	1	2020-09-14
16714-086-03	EA - Each	16714-086	5954138d-6974-4660-9a27-786510ba2ad0	1	2020-09-14
16714-086-04	EA - Each	16714-086	85cfe36d-cab8-4b93-b0b6-5ee3442854ec	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-086	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [NORTHSTAR RX LLC]	5	Legacy NDC	20240802_2aead427-3e25-4a87-a858-f2bd7642baf5.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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	Sun Pharmaceutical Industries, Inc.	c23b6b9b-aec3-48a8-a518-76e4097f6479	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	be4aa233-1555-4972-858e-46343a710558	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	11d06acd-1351-4afd-a16a-f035758e2a27	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	ca194a2a-ed16-40f6-a78c-45c5f3392170	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	ebc4efec-7895-4298-8e75-360bb7992f8d	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	813d199a-9004-4102-8ade-cf877caedafb	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	bb1423e8-1517-44c5-98e0-99be24ce269b	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	2d0655d7-fda6-40c6-907c-acaba0e19987	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	1c31c953-05ce-475a-b93f-80aeb12bde95	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	10a5c989-66e3-494d-bfd8-b2d6df3be411	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	753bbc6f-2e50-49c1-b5bf-18f8411a1e8e	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cae68fd6-5161-4650-bcde-6db98cbe6c8b	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	3791d79c-d960-4790-b689-ea32ddf7226a	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cbc817de-5ea8-4139-9c13-02bac8ff93c3	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	2efb4720-625f-6616-b6f0-8b13a17c9d7e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	d4cf1136-df3a-4fc2-9a21-9032949eca41	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	45232668-6952-80a0-e063-6294a90a6e4b	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	REMEDYREPACK INC.	7c59e03a-b058-4f6e-b104-0836d9b56392	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	1b29888c-09f9-4cd5-9b4c-920bd159a727	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424

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	f98e8ce9-4dbf-2740-e053-6394a90a5ddb	1
198222	spironolactone 100 MG Oral Tablet	SCD	f98e8ce9-4dbf-2740-e053-6394a90a5ddb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-086-02	16714008602	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-086-02)	2020-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE	NorthStar Rx LLC \| Frontida BioPharm, Inc.	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	7
SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL	1