Enalapril Maleate

Product NDC: 51672-4039
Requested package NDC: 51672-4039-1
11-digit product format: 516724039
Labeler code: 51672
Product ID: 51672-4039_cd383c43-f111-4ea1-99e1-8849c555ee91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA075657
Marketing category: ANDA
Marketing start: 2001-01-23
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51672-4039	51672-4039-1	D	Discontinued by firm		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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-4039	51672-4039-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-4039	51672-4039-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-4039-1	Enalapril Maleate	100 in 1 BOTTLE	TABLET	100		13
51672-4039-3	Enalapril Maleate	1000 in 1 BOTTLE	TABLET	1000		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4039-1	EA - Each	51672-4039	85d54e4d-042c-4988-a07a-c260f3b126d6	1	2013-02-13
51672-4039-3	EA - Each	51672-4039	73d1f8af-0fe5-4d4a-9855-fe1c29def96b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Enalapril Maleate	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Enalaprilat Anhydrous	ACTIVE MOIETY	Q508Q118JM	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Sodium Bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Enalapril Maleate	ACTIVE INGREDIENT	9O25354EPJ	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
ENALAPRILAT ANHYDROUS	ACTIVE MOIETY	Q508Q118JM	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
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
51672-4039	ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	13	Legacy NDC, 2 package rows	20230728_f103b9f9-e081-419d-a2d8-b86acda834dd.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 ndc (package): 51672-4039-1 ndc (product): 51672-4039 ndc11 (package): 51672403901
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	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	1032
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	1032
858810	enalapril maleate 20 MG Oral Tablet	PSN	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	1032
858817	enalapril maleate 10 MG Oral Tablet	SCD	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	1032
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	1032
858810	enalapril maleate 20 MG Oral Tablet	SCD	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	1032
858817	enalapril maleate 10 MG Oral Tablet	PSN	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858810	enalapril maleate 20 MG Oral Tablet	PSN	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858813	enalapril maleate 5 MG Oral Tablet	PSN	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858817	enalapril maleate 10 MG Oral Tablet	SCD	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858810	enalapril maleate 20 MG Oral Tablet	SCD	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858813	enalapril maleate 5 MG Oral Tablet	SCD	f103b9f9-e081-419d-a2d8-b86acda834dd	13
858817	enalapril maleate 10 MG Oral Tablet	PSN	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858810	enalapril maleate 20 MG Oral Tablet	PSN	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858813	enalapril maleate 5 MG Oral Tablet	PSN	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858817	enalapril maleate 10 MG Oral Tablet	SCD	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858810	enalapril maleate 20 MG Oral Tablet	SCD	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858813	enalapril maleate 5 MG Oral Tablet	SCD	0a12343f-5733-40cc-93b4-a02f5147fb91	11
858817	enalapril maleate 10 MG Oral Tablet	PSN	0f7c3734-e05b-7082-e054-00144ff88e88	1
858817	enalapril maleate 10 MG Oral Tablet	PSN	b3ee3b05-8740-cd17-e053-2a95a90a6e28	1
858810	enalapril maleate 20 MG Oral Tablet	PSN	0f7c3734-e05b-7082-e054-00144ff88e88	1
858817	enalapril maleate 10 MG Oral Tablet	SCD	0f7c3734-e05b-7082-e054-00144ff88e88	1
858817	enalapril maleate 10 MG Oral Tablet	SCD	b3ee3b05-8740-cd17-e053-2a95a90a6e28	1
858810	enalapril maleate 20 MG Oral Tablet	SCD	0f7c3734-e05b-7082-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4039-1	51672403901	100 TABLET in 1 BOTTLE (51672-4039-1)	100 tablet	2001-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enalapril Maleate Tablets, USP	Bryant Ranch Prepack	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	1033
Enalapril Maleate Tablets, USP	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceuticals Industries Ltd.	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	14
Enalapril Maleate Tablets, USP	A-S Medication Solutions	2025-05-07	HUMAN PRESCRIPTION DRUG LABEL	12
Enalapril Maleate Tablets, USP	Golden State Medical Supply, Inc.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	11
Enalapril Maleate Tablets, USP	Northwind Pharmaceuticals, LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	3
Enalapril Maleate Tablets, USP	Preferred Pharmaceuticals Inc.	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL	4
Enalapril Maleate Tablets, USP	Bryant Ranch Prepack	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	101
Enalapril Maleate Tablets, USP	REMEDYREPACK INC.	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	9
Enalapril Maleate Tablets, USP	NuCare Pharmaceuticals,Inc.	2021-06-01	HUMAN PRESCRIPTION DRUG LABEL	1
Enalapril Maleate Tablets, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-08	HUMAN PRESCRIPTION DRUG LABEL	1
ENALAPRIL MALEATE	direct rx	2020-11-12	HUMAN PRESCRIPTION DRUG LABEL	1
Enalapril Maleate Tablets, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	1
Enalapril Maleate Tablets, USP	REMEDYREPACK INC.	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL	3
Enalapril Maleate Tablets, USP	Blenheim Pharmacal, Inc.	2015-02-19	HUMAN PRESCRIPTION DRUG LABEL	1