ENALAPRIL MALEATE

Product NDC: 71205-074
11-digit product format: 712050074
Labeler code: 71205
Product ID: 71205-074_12772669-8d4e-4aa0-a911-131638db74fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENALAPRIL MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA075483
Marketing category: ANDA
Marketing start: 2009-12-11
Marketing end: 0000-00-00
Substance: ENALAPRIL MALEATE
Active strength: 5 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: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71205-074		D	Discontinued by firm	2026-10-12
excluded package	package	71205-074	71205-074-30	D	Discontinued by firm	2026-10-12
excluded package	package	71205-074	71205-074-60	D	Discontinued by firm	2026-10-12
excluded package	package	71205-074	71205-074-90	D	Discontinued by firm	2026-10-12

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 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075483-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075483-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075483-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075483-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075483-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075483-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075483-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075483-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075483-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075483-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075483-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075483-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075483-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075483-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075483-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075483-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075483-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075483-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075483-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075483-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075483-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075483-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075483-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075483-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075483-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075483-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075483-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075483-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075483-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075483-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075483-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075483-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075483-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075483-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075483-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075483-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075483-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075483-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075483-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075483-004	AB	1	`74a2ff9319b5…`

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
71205-074-90	EA - Each	71205-074	d194e2d8-14de-442d-975e-92a94b7ab218	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-074	ENALAPRIL MALEATE TABLET [PROFICIENT RX LP]	3	Legacy NDC	20191030_ccf975b6-5241-48e5-9f63-d90862c46f88.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-074-30	71205007430	30 TABLET in 1 BOTTLE (71205-074-30)	30 tablet	2018-07-02	0000-00-00	No	No	Current
71205-074-60	71205007460	60 TABLET in 1 BOTTLE (71205-074-60)	60 tablet	2018-07-02	0000-00-00	No	No	Current
71205-074-90	71205007490	90 TABLET in 1 BOTTLE (71205-074-90)	90 tablet	2018-07-02	0000-00-00	No	No	Current