Enalapril maleate

Product NDC: 51655-006
Requested package NDC: 51655-006-26
11-digit product format: 516550006
Labeler code: 51655
Product ID: 51655-006_498a68a5-e657-bb66-e063-6294a90a5911
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril maleate
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA075479
Marketing category: ANDA
Marketing start: 2022-07-11
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075479-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22
A075479-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22
A075479-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22
A075479-004	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
A075479-001	AB
A075479-002	AB
A075479-003	AB
A075479-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075479-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075479-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075479-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075479-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075479-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075479-004	AB	1	`d06236e962d9…`

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	10 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
858817	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
f29ef93b-7380-2196-e053-2995a90a2ce3	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	Strength	SPL version
51655-006-26	Enalapril maleate	90 in 1 BOTTLE, PLASTIC	TABLET	90		4
51655-006-52	Enalapril maleate	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-006	ENALAPRIL MALEATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 2 package rows	20240704_f29ef93b-7380-2196-e053-2995a90a2ce3.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril maleate	ENALAPRIL MALEATE	A-S Medication Solutions	9f913e79-fe6d-4ff2-9f8e-eef9df689fa8	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Legacy Pharmaceutical Packaging, LLC	ed7536f1-9a7d-4519-e053-2a95a90a4a65	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Major Pharmaceuticals	8fe8dc52-dee6-4d33-b798-e90128011f46	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f29ef93b-7380-2196-e053-2995a90a2ce3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479 ndc (package): 51655-006-26 ndc (product): 51655-006 ndc11 (package): 51655000626
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f2a0bd73-0389-3f88-e053-2995a90a72e8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f2b3776b-02a1-311b-e053-2a95a90a2f9b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	5c49fb37-1f09-4965-b213-5580d3a30a11	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	7077d32e-4b06-4d48-ba0c-6db2f8ebe08c	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Chartwell RX, LLC	b1df1832-dce4-443f-87fc-e4177d069035	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	A-S Medication Solutions	ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479

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	f29ef93b-7380-2196-e053-2995a90a2ce3	4
858817	enalapril maleate 10 MG Oral Tablet	SCD	f29ef93b-7380-2196-e053-2995a90a2ce3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-006-26	51655000626	90 TABLET in 1 BOTTLE, PLASTIC (51655-006-26)	90 tablet	2022-09-06	No	No	Current