Enalapril Maleate and Hydrochlorothiazide

Product NDC: 21695-780
11-digit product format: 216950780
Labeler code: 21695
Product ID: 21695-780_c1d62153-8622-40de-a20b-3faecd718736
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril Maleate and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075788
Marketing category: ANDA
Marketing start: 2001-09-18
Marketing end: 0000-00-00
Substance: ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-780		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-780	21695-780-30	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 · 44 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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`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	21695-780-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-780-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-780-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-780-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-780-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-780-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-780-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-780-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-780-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-780-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-780-30	`110d247fa046…`	`a55b01930146…`

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

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
A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB		2001-09-18
A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB		2001-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075788-001	AB
A075788-002	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 · 84 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	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A075788-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075788-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075788-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075788-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075788-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075788-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075788-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075788-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075788-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075788-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075788-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075788-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075788-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075788-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075788-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075788-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075788-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075788-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
5ffbd585-373a-fcf5-c6c8-1f04bf28013e	Product name	3	20250331
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
2c0b09af-323c-477d-9a19-d8165aefa3b0	Product name	4	20250107
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-780-30	2019-09-24	C162847	48780-1	934fe258-4c7d-48b1-e053-8cdaa90a720a	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-780-30	Enalapril Maleate and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-780-30	EA - Each	21695-780	a99d072b-6282-43da-b580-1816a7724cd4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Enalapril Maleate	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
Hydrochlorothiazide	ACTIVE INGREDIENT	0J48LPH2TH	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
Enalapril	ACTIVE MOIETY	69PN84IO1A	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
Hydrochlorothiazide	ACTIVE MOIETY	0J48LPH2TH	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERROUS OXIDE	INACTIVE INGREDIENT	G7036X8B5H	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-780	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110103_c1d62153-8622-40de-a20b-3faecd718736.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
Enalapril Maleate and Hydrochlorothiazide	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	Sun Pharmaceutical Industries, Inc.	7cb92cf2-46f2-4379-937c-168d230e43a4	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075788 application number: ANDA075788

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9O25354EPJ	ENALAPRIL MALEATE	76095-16-4	ENALAPRIL MALEATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858828	enalapril maleate 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	c1d62153-8622-40de-a20b-3faecd718736	1
858828	enalapril maleate 10 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	c1d62153-8622-40de-a20b-3faecd718736	1
858828	enalapril maleate 10 MG / HCTZ 25 MG Oral Tablet	SY	c1d62153-8622-40de-a20b-3faecd718736	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-780-30	21695078030	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP	Rebel Distributors Corp	2010-12-20	HUMAN PRESCRIPTION DRUG LABEL	1