Ethacrynic acid

Product NDC: 72134-003
Requested package NDC: 72134-003-01
11-digit product format: 721340003
Labeler code: 72134
Product ID: 72134-003_d1cbe78b-a960-4595-84c5-7b8f91109f01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethacrynic acid
Dosage form: TABLET
Route: ORAL
Labeler: Agnitio Inc.
Application: ANDA211809
Marketing category: ANDA
Marketing start: 2019-05-30
Marketing end: 0000-00-00
Substance: ETHACRYNIC ACID
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	72134-003	72134-003-01	I	Inactivated by FDA		2026-08-17

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 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211809-001	ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB		2019-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211809-001	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 2 · 41 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
2026-08-18 06:07:40	2026-07	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211809-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-07-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211809-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211809-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211809-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211809-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211809-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211809-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211809-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211809-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211809-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211809-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211809-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211809-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211809-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211809-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211809-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211809-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211809-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211809-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211809-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211809-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211809-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211809-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211809-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211809-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211809-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211809-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211809-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211809-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211809-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211809-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211809-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211809-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211809-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211809-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211809-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211809-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211809-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211809-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211809-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211809-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
93aead9c-5c26-5d19-73e9-d6c55a939061	Product name	9	20210525
01098bd8-4859-4cc2-9426-3489bf88d451	Product name	4	20201216

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72134-003-01	2023-01-30	C162847	48780-1	f386c64a-09eb-0266-e053-dadaa90a7c1a	Ethacrynic Acid Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72134-003-01	Ethacrynic acid	100 in 1 BOTTLE	TABLET	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72134-003	ETHACRYNIC ACID TABLET [AGNITIO INC.]	3	Legacy NDC, 1 package rows	20210129_409c9c72-0693-4d58-bcfe-e71567ed49a0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethacrynic acid	ETHACRYNIC ACID	TRUPHARMA LLC	3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211809 application number: ANDA211809

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M5DP350VZV	ETHACRYNIC ACID	58-54-8	ETHACRYNIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1251903	ethacrynic acid 25 MG Oral Tablet	PSN	409c9c72-0693-4d58-bcfe-e71567ed49a0	3
1251903	ethacrynic acid 25 MG Oral Tablet	SCD	409c9c72-0693-4d58-bcfe-e71567ed49a0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72134-003-01	72134000301	100 TABLET in 1 BOTTLE (72134-003-01)	100 tablet	2019-05-30	0000-00-00	No	No	Current