ENALAPRIL MALEATE

Product NDC: 68788-4147
11-digit product format: 687884147
Labeler code: 68788
Product ID: 68788-4147_eee8633b-9d9e-453d-8c6b-8b13c94d2f58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENALAPRIL MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA218531
Marketing category: ANDA
Marketing start: 2026-07-10
Substance: ENALAPRIL MALEATE
Active strength: 20 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: 2027-12-31
Current FDA listing: Yes

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
A218531-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19
A218531-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19
A218531-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19
A218531-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218531-001	AB
A218531-002	AB
A218531-003	AB
A218531-004	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 2 · 48 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	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A218531-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218531-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218531-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218531-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218531-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218531-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218531-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-004	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-004	AB	1	`d8e5a09893c0…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ENALAPRIL MALEATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENALAPRIL MALEATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9O25354EPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858810	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eee8633b-9d9e-453d-8c6b-8b13c94d2f58	Available on FDA.report

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 · 5 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	fa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	b31372f7-cda3-4ead-a481-4cde62e843fd	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	eee8633b-9d9e-453d-8c6b-8b13c94d2f58	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531 ndc (product): 68788-4147
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Bryant Ranch Prepack	c1e4cd79-ece5-432c-bd3a-ed4633ccec70	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Rising Pharma Holdings, Inc.	71e9fff3-7283-437e-b107-72fc16f09989	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531

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	Sample	Exclude flag	Status
68788-4147-0	68788414700	100 TABLET in 1 BOTTLE (68788-4147-0)	100 tablet	2026-07-10	No	No	Current
68788-4147-3	68788414703	30 TABLET in 1 BOTTLE (68788-4147-3)	30 tablet	2026-07-10	No	No	Current
68788-4147-6	68788414706	60 TABLET in 1 BOTTLE (68788-4147-6)	60 tablet	2026-07-10	No	No	Current
68788-4147-9	68788414709	90 TABLET in 1 BOTTLE (68788-4147-9)	90 tablet	2026-07-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enalapril Maleate Tablets, USP	Preferred Pharmaceuticals Inc.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	1