SPIRONOLACTONE

Product NDC: 0574-1133
11-digit product format: 005741133
Labeler code: 0574
Product ID: 0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: SUSPENSION
Route: ORAL
Labeler: Padagis US LLC
Application: NDA209478
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-10-31
Substance: SPIRONOLACTONE
Active strength: 25 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209478-001	CAROSPIR	SPIRONOLACTONE	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209478-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209478-001	10493083	2036-10-28		Drug product	2020-01-02
N209478-001	10624906	2036-10-28		Drug product	2020-04-27
N209478-001	10660907	2036-10-28		Drug product	2020-06-15
N209478-001	10888570	2036-10-28		Drug product	2021-01-15
N209478-001	11389461	2036-10-28		Drug product	2022-07-22
N209478-001	11395828	2036-10-28	U-2109		2022-08-02
N209478-001	11395828	2036-10-28	U-3401		2022-08-02
N209478-001	11395828	2036-10-28	U-3402		2022-08-02
N209478-001	11491166	2036-10-28		Drug product	2022-11-18
N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2017-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209478-001	CAROSPIR	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2017-08-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209478-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209478-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209478-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209478-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209478-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209478-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209478-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209478-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209478-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209478-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209478-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209478-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209478-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209478-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209478-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209478-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209478-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209478-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 319 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10493083	2036-10-28		Drug product	2020-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10624906	2036-10-28		Drug product	2020-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10660907	2036-10-28		Drug product	2020-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	10888570	2036-10-28		Drug product	2021-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11389461	2036-10-28		Drug product	2022-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11395828	2036-10-28	U-2109		2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11395828	2036-10-28	U-3401		2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11395828	2036-10-28	U-3402		2022-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	11491166	2036-10-28		Drug product	2022-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209478-001	9757394	2036-10-28	U-2109	Drug product	2017-09-21	`fd3edfee7708…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	25 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104232	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
522bd365-ddcc-48f4-8a98-66dc4c3bb314	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0574-1133-04	SPIRONOLACTONE	118 mL in 1 BOTTLE	SUSPENSION	118	3
0574-1133-05	SPIRONOLACTONE	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	3
0574-1133-10	SPIRONOLACTONE	10 in 1 CARTON	SUSPENSION	10	3
0574-1133-16	SPIRONOLACTONE	473 mL in 1 BOTTLE	SUSPENSION	473	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-1133	SPIRONOLACTONE SUSPENSION [PADAGIS US LLC]	3	Current NDC, 4 package rows	20250103_522bd365-ddcc-48f4-8a98-66dc4c3bb314.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	ATLANTIC BIOLOGICALS CORP.	122558a0-57bb-4195-9adf-d37b049cbfb5	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209478 application number: NDA209478
SPIRONOLACTONE	SPIRONOLACTONE	Padagis US LLC	522bd365-ddcc-48f4-8a98-66dc4c3bb314	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209478 application number: NDA209478 ndc (product): 0574-1133
CaroSpir	CAROSPIR	CMP Pharma, Inc.	c4f70a04-7d89-4b73-8b02-17d43471bf08	2023-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209478 application number: NDA209478

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
104232	spironolactone 25 MG in 5 mL Oral Suspension	PSN	122558a0-57bb-4195-9adf-d37b049cbfb5	6
104232	spironolactone 5 MG/ML Oral Suspension	SCD	122558a0-57bb-4195-9adf-d37b049cbfb5	6
104232	spironolactone 25 MG per 5 ML Oral Suspension	SY	122558a0-57bb-4195-9adf-d37b049cbfb5	6
104232	spironolactone 25 MG in 5 mL Oral Suspension	PSN	522bd365-ddcc-48f4-8a98-66dc4c3bb314	3
104232	spironolactone 5 MG/ML Oral Suspension	SCD	522bd365-ddcc-48f4-8a98-66dc4c3bb314	3
104232	spironolactone 25 MG per 5 ML Oral Suspension	SY	522bd365-ddcc-48f4-8a98-66dc4c3bb314	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0574-1133-04	00574113304	118 mL in 1 BOTTLE (0574-1133-04)	118 ml	2023-10-31	No	No	Current
0574-1133-05	00574113305	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
0574-1133-10	00574113310	10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)		2023-10-31	No	No	Current
0574-1133-16	00574113316	473 mL in 1 BOTTLE (0574-1133-16)	473 ml	2023-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE	ATLANTIC BIOLOGICALS CORP.	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	7
SPIRONOLACTONE	Padagis US LLC	2025-01-01	HUMAN PRESCRIPTION DRUG LABEL	3