Ethacrynic Acid

Product NDC: 60760-773
11-digit product format: 607600773
Labeler code: 60760
Product ID: 60760-773_4c265ce1-7fa6-98f1-e063-6294a90ad0c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethacrynic Acid
Dosage form: TABLET
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA211232
Marketing category: ANDA
Marketing start: 2023-02-09
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: 2027-12-31
Current FDA listing: Yes

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
A211232-001	ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB		2019-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211232-001	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	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211232-001	ETHACRYNIC ACID	25MG	TABLET / ORAL	AB	2019-08-27	`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	A211232-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211232-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211232-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211232-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211232-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211232-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211232-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211232-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211232-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211232-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211232-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211232-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211232-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211232-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211232-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211232-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211232-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211232-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211232-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211232-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211232-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211232-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211232-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211232-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211232-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211232-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211232-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211232-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211232-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211232-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211232-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211232-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211232-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211232-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211232-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211232-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211232-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211232-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211232-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211232-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ethacrynic Acid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETHACRYNIC ACID	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M5DP350VZV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1251903	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
f4e95ca1-502b-5305-e053-2995a90a5dc7	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60760-773-30	Ethacrynic Acid	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
60760-773-60	Ethacrynic Acid	60 in 1 BOTTLE, PLASTIC	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-773-30	EA - Each	60760-773	30d9db28-29b3-47f1-99a2-15ef81ad0440	1	2023-04-07
60760-773-60	EA - Each	60760-773	bde6d33c-32b4-44e7-a503-c31edd52e9e6	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-773	ETHACRYNIC ACID TABLET [ST. MARY'S MEDICAL PARK PHARMACY]	1	Current NDC, 2 package rows	20230219_f4e95ca1-502b-5305-e053-2995a90a5dc7.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
Ethacrynic Acid	ETHACRYNIC ACID	St. Mary's Medical Park Pharmacy	f4e95ca1-502b-5305-e053-2995a90a5dc7	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211232 application number: ANDA211232 ndc (product): 60760-773
Ethacrynic Acid	ETHACRYNIC ACID	Bryant Ranch Prepack	fd1b7fb4-fe56-4f2d-860d-bbcea16adfea	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211232 application number: ANDA211232
Ethacrynic Acid	ETHACRYNIC ACID	ScieGen Pharmaceuticals Inc	d400d264-c231-4bdf-8180-eb11ab4e9f29	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211232 application number: ANDA211232

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	f4e95ca1-502b-5305-e053-2995a90a5dc7	2
1251903	ethacrynic acid 25 MG Oral Tablet	SCD	f4e95ca1-502b-5305-e053-2995a90a5dc7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-773-30	60760077330	30 TABLET in 1 BOTTLE, PLASTIC (60760-773-30)	30 tablet	2023-02-09	No	No	Current
60760-773-60	60760077360	60 TABLET in 1 BOTTLE, PLASTIC (60760-773-60)	60 tablet	2023-02-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETHACRYNIC ACID TABLETS, USP	St. Mary's Medical Park Pharmacy	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	3