Enalapril Maleate

Product NDC: 10544-195
11-digit product format: 105440195
Labeler code: 10544
Product ID: 10544-195_1044ee11-1d9d-5435-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA075657
Marketing category: ANDA
Marketing start: 2013-11-25
Marketing end: 0000-00-00
Substance: ENALAPRIL MALEATE
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
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	10544-195		I	Inactivated by FDA		2026-08-17
excluded package	package	10544-195	10544-195-90	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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-195-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-195-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-195-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-195-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-195-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-195-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-195-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-195-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-195-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-195-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-195-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-195-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-195-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-195-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-195-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-195-90	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-195-90	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-195-90	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-195-90	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-195-90	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10544-195-90	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10544-195-90	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075657-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23
A075657-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23
A075657-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23
A075657-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075657-001	AB
A075657-002	AB
A075657-003	AB
A075657-004	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 5 · 168 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	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2001-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2001-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2001-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2001-01-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A075657-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075657-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075657-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075657-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075657-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075657-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075657-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075657-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075657-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075657-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075657-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075657-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075657-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075657-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075657-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075657-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075657-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075657-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075657-004	AB	1	`d8e5a09893c0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ffbd585-373a-fcf5-c6c8-1f04bf28013e	Product name	3	20250331
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-195-90	2020-01-31	C162847	48780-1	9d75b9d0-ddec-f424-e053-dadaa90a57ce	Enalapril Maleate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-195-90	Enalapril Maleate	90 in 1 BOTTLE	TABLET	90		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ENALAPRIL MALEATE	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
ENALAPRILAT ANHYDROUS	ACTIVE MOIETY	Q508Q118JM	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-195	ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20150302_1044ee11-1d9c-5435-e054-00144ff88e88.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Sun Pharmaceutical Industries, Inc.	f103b9f9-e081-419d-a2d8-b86acda834dd	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	bc875f91-d781-43a9-8f7e-e2cfc019ad3f	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	ab2ffb6e-4628-e44c-e053-2a95a90a2336	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	3fbc6cce-7ad5-49d5-9705-5f66ef92d544	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Golden State Medical Supply, Inc.	0a12343f-5733-40cc-93b4-a02f5147fb91	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	bdb34c96-1532-4ce5-93a7-3cc90904c910	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2061543d-67e7-46b6-aa56-cafa11ae4b93	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	0ad4bfb4-62db-4759-af60-88eb031d125a	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Golden State Medical Supply, Inc.	074fe718-88d8-365c-e063-6394a90a299d	2023-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	f3754f29-9b75-4e2c-9c28-b3479f5bf906	2023-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	b4b7b936-4a62-4991-8d3c-03bb37f044c1	2023-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657
Enalapril Maleate	ENALAPRIL MALEATE	Proficient Rx LP	ca1d0143-bbd3-4041-9981-eadbb8893a2b	2020-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075657 application number: ANDA075657

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9O25354EPJ	ENALAPRIL MALEATE	76095-16-4	ENALAPRIL MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858817	enalapril maleate 10 MG Oral Tablet	PSN	1044ee11-1d9c-5435-e054-00144ff88e88	1
858813	enalapril maleate 5 MG Oral Tablet	PSN	1044ee11-1d9c-5435-e054-00144ff88e88	1
858817	enalapril maleate 10 MG Oral Tablet	SCD	1044ee11-1d9c-5435-e054-00144ff88e88	1
858813	enalapril maleate 5 MG Oral Tablet	SCD	1044ee11-1d9c-5435-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-195-90	10544019590	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enalapril Maleate Tablets, USP	Blenheim Pharmacal, Inc.	2015-03-01	HUMAN PRESCRIPTION DRUG LABEL	1