ENALAPRIL MALEATE

Product NDC: 69292-540
11-digit product format: 692920540
Labeler code: 69292
Product ID: 69292-540_c55c2c6a-bb5e-4ac7-8380-6530d2f6623b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: enalapril maleate
Dosage form: TABLET
Route: ORAL
Labeler: Amici Pharma, Inc
Application: ANDA075483
Marketing category: ANDA
Marketing start: 2025-10-15
Substance: ENALAPRIL MALEATE
Active strength: 2.5 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A075483-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075483-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075483-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075483-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A075483-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075483-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075483-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075483-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075483-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075483-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075483-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075483-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075483-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075483-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075483-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075483-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075483-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075483-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075483-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075483-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075483-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075483-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075483-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075483-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075483-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075483-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075483-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075483-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075483-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075483-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075483-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075483-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075483-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075483-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075483-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075483-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075483-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075483-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075483-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075483-004	AB	1	`ea99ee380514…`

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	2.5 mg/1

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
69292-540-01	ENALAPRIL MALEATE	100 in 1 BOTTLE	TABLET	100		2
69292-540-10	ENALAPRIL MALEATE	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69292-540-01	EA - Each	69292-540	456c92b8-0942-475f-aad8-00af1b6cb6f9	1	2025-11-13
69292-540-10	EA - Each	69292-540	564112bb-b17e-4593-938c-70e7cb854115	1	2025-11-13

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	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858810	enalapril maleate 20 MG Oral Tablet	PSN	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858813	enalapril maleate 5 MG Oral Tablet	PSN	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858817	enalapril maleate 10 MG Oral Tablet	SCD	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858810	enalapril maleate 20 MG Oral Tablet	SCD	a88902bd-742f-4ea6-b625-cc9df1709efc	2
858813	enalapril maleate 5 MG Oral Tablet	SCD	a88902bd-742f-4ea6-b625-cc9df1709efc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69292-540-01	69292054001	100 TABLET in 1 BOTTLE (69292-540-01)	100 tablet	2025-10-15	No	No	Current
69292-540-10	69292054010	1000 TABLET in 1 BOTTLE (69292-540-10)	1000 tablet	2025-10-15	No	No	Current