Fosinopril Sodium and Hydrochlorothiazide

Product NDC: 57237-027
11-digit product format: 572370027
Labeler code: 57237
Product ID: 57237-027_575c1e7b-80be-4520-ad70-3f2444c47e55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril Sodium and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Rising Health, LLC
Application: ANDA079245
Marketing category: ANDA
Marketing start: 2009-07-09
Marketing end: 0000-00-00
Substance: FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength: 20 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57237-027		D	Discontinued by firm	2026-10-05
excluded package	package	57237-027	57237-027-01	D	Discontinued by firm	2026-10-05
excluded package	package	57237-027	57237-027-30	D	Discontinued by firm	2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57237-027-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57237-027-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57237-027-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57237-027-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57237-027-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57237-027-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57237-027-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57237-027-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57237-027-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57237-027-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57237-027-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57237-027-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57237-027-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57237-027-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57237-027-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57237-027-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57237-027-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57237-027-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57237-027-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57237-027-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57237-027-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57237-027-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57237-027-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57237-027-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09
A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A079245-001	AB
A079245-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RS	2009-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079245-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079245-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2009-07-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A079245-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079245-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079245-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079245-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079245-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079245-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079245-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079245-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079245-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079245-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079245-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079245-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079245-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079245-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079245-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079245-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079245-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079245-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079245-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079245-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079245-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A079245-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079245-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A079245-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079245-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079245-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079245-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079245-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079245-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079245-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079245-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079245-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079245-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A079245-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079245-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A079245-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079245-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079245-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079245-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079245-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-027-01	EA - Each	57237-027	1acea847-e2ce-4b70-966b-6f1cf65a7a1e	1	2014-04-03
57237-027-30	EA - Each	57237-027	05321417-0cdf-4a12-8451-545e263352a6	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSINOPRIL SODIUM	ACTIVE INGREDIENT	NW2RTH6T2N	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
FOSINOPRILAT	ACTIVE MOIETY	S312EY6ZT8	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CITRON PHARMA LLC]	1

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
Fosinopril Sodium and Hydrochlorothiazide	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	35019655-9a30-4305-a262-936ad0e73071	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079245 application number: ANDA079245

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-027-01	57237002701	100 TABLET in 1 BOTTLE (57237-027-01)	100 tablet	2009-07-09	0000-00-00	No	No	Current
57237-027-30	57237002730	30 TABLET in 1 BOTTLE (57237-027-30)	30 tablet	2009-07-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosinopril Sodium and Hydrochlorothiazide Tablets, USP Rx only	Rising Health, LLC \| Aurobindo Pharma Limited	2020-04-27	Human Prescription Drug Label	5