Enalapril Maleate

Product NDC: 63187-977
11-digit product format: 631870977
Labeler code: 63187
Product ID: 63187-977_386e877f-e67d-4f4a-964d-ca85afc1ba32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA075657
Marketing category: ANDA
Marketing start: 2001-01-23
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Enalapril Maleate
Listing expiration: 2026-12-31

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
ca1d0143-bbd3-4041-9981-eadbb8893a2b	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-977-30	Enalapril Maleate	30 in 1 BOTTLE	TABLET	30	4
63187-977-60	Enalapril Maleate	60 in 1 BOTTLE	TABLET	60	4
63187-977-90	Enalapril Maleate	90 in 1 BOTTLE	TABLET	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-977-90	EA - Each	63187-977	2a058861-3ca5-4352-ae68-d94be74586d4	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-977	ENALAPRIL MALEATE TABLET [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 3 package rows	20200313_ca1d0143-bbd3-4041-9981-eadbb8893a2b.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 ndc (product): 63187-977

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
858810	enalapril maleate 20 MG Oral Tablet	PSN	ca1d0143-bbd3-4041-9981-eadbb8893a2b	4
858810	enalapril maleate 20 MG Oral Tablet	SCD	ca1d0143-bbd3-4041-9981-eadbb8893a2b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-977-30	63187097730	30 TABLET in 1 BOTTLE (63187-977-30)	30 tablet	2018-02-01	0000-00-00	No	No	Current
63187-977-60	63187097760	60 TABLET in 1 BOTTLE (63187-977-60)	60 tablet	2018-02-01	0000-00-00	No	No	Current
63187-977-90	63187097790	90 TABLET in 1 BOTTLE (63187-977-90)	90 tablet	2018-02-01	0000-00-00	No	No	Current