ENALAPRIL MALEATE

Product NDC: 55648-923
11-digit product format: 556480923
Labeler code: 55648
Product ID: 55648-923_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENALAPRIL MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: Wockhardt Limited
Application: ANDA075483
Marketing category: ANDA
Marketing start: 2009-12-11
Marketing end: 0000-00-00
Substance: ENALAPRIL MALEATE
Active strength: 3 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-923		I	Inactivated by FDA	2026-09-14
excluded package	package	55648-923	55648-923-01	I	Inactivated by FDA	2026-09-14
excluded package	package	55648-923	55648-923-02	I	Inactivated by FDA	2026-09-14
excluded package	package	55648-923	55648-923-03	I	Inactivated by FDA	2026-09-14
excluded package	package	55648-923	55648-923-07	I	Inactivated by FDA	2026-09-14
excluded package	package	55648-923	55648-923-09	I	Inactivated by FDA	2026-09-14
excluded package	package	55648-923	55648-923-10	I	Inactivated by FDA	2026-09-14

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 3 · 147 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	55648-923-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-923-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-923-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-923-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-923-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-923-02	`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	55648-923-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-923-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-923-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-923-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-923-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-923-02	`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	55648-923-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-923-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-923-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-923-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-923-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-923-02	`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	55648-923-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-923-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-923-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-923-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-923-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-923-02	`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	55648-923-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-923-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-923-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-923-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-923-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-923-02	`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	55648-923-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-923-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-923-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-923-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-923-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-923-02	`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	55648-923-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-923-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-923-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-923-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-923-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-923-02	`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	55648-923-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-923-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-923-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-923-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-923-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-923-02	`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	55648-923-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-923-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-923-01	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A075483-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22
A075483-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22
A075483-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22
A075483-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075483-001	AB
A075483-002	AB
A075483-003	AB
A075483-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075483-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075483-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075483-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075483-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075483-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075483-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075483-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075483-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075483-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075483-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075483-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075483-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075483-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075483-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075483-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075483-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075483-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075483-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075483-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075483-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075483-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075483-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

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
628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
55648-923-01	ENALAPRIL MALEATE TABLETS, USP
55648-923-02	ENALAPRIL MALEATE TABLETS, USP
55648-923-03	ENALAPRIL MALEATE TABLETS, USP
55648-923-07	ENALAPRIL MALEATE TABLETS, USP
55648-923-09	ENALAPRIL MALEATE TABLETS, USP
55648-923-10	ENALAPRIL MALEATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-923-01	ENALAPRIL MALEATE	90 in 1 BOTTLE	TABLET	90	3
55648-923-02	ENALAPRIL MALEATE	100 in 1 BOTTLE	TABLET	100	3
55648-923-03	ENALAPRIL MALEATE	1000 in 1 BOTTLE	TABLET	1000	3
55648-923-07	ENALAPRIL MALEATE	10 in 1 BLISTER PACK	TABLET	10	3
55648-923-07	ENALAPRIL MALEATE	10 in 1 CARTON	TABLET	10	3
55648-923-09	ENALAPRIL MALEATE	40000 in 1 DRUM	TABLET	40000	3
55648-923-10	ENALAPRIL MALEATE	8000 in 1 DRUM	TABLET	8000	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ENALAPRIL MALEATE	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
ENALAPRILAT ANHYDROUS	ACTIVE MOIETY	Q508Q118JM	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-923	ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED]	3	Legacy NDC, 7 package rows	20151124_f1ec6ac1-6b94-40bb-a329-9056f201090c.zip

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	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858810	enalapril maleate 20 MG Oral Tablet	PSN	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858813	enalapril maleate 5 MG Oral Tablet	PSN	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858817	enalapril maleate 10 MG Oral Tablet	SCD	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858810	enalapril maleate 20 MG Oral Tablet	SCD	f1ec6ac1-6b94-40bb-a329-9056f201090c	3
858813	enalapril maleate 5 MG Oral Tablet	SCD	f1ec6ac1-6b94-40bb-a329-9056f201090c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-923-01	55648092301	90 in 1 BOTTLE	Historical
55648-923-02	55648092302	100 in 1 BOTTLE	Historical
55648-923-03	55648092303	1000 in 1 BOTTLE	Historical
55648-923-07	55648092307	10 in 1 BLISTER PACK	Historical
55648-923-09	55648092309	40000 in 1 DRUM	Historical
55648-923-10	55648092310	8000 in 1 DRUM	Historical