ENALAPRIL MALEATE

Product NDC: 63304-525
11-digit product format: 633040525
Labeler code: 63304
Product ID: 63304-525_c9c61aa4-3278-4366-b292-e9a7e321fc8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENALAPRIL MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: Ranbaxy Pharmaceuticals Inc.
Application: ANDA075556
Marketing category: ANDA
Marketing start: 2016-09-17
Marketing end: 0000-00-00
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: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-525		I	Inactivated by FDA	2026-10-16
excluded package	package	63304-525	63304-525-01	I	Inactivated by FDA	2026-10-16
excluded package	package	63304-525	63304-525-10	I	Inactivated by FDA	2026-10-16

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-525-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-525-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-525-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-525-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-525-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-525-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-525-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-525-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-525-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-525-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-525-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-525-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-525-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-525-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-525-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-525-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-525-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-525-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-525-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-525-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-525-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-525-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-525-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-525-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-525-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-525-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-525-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-525-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-525-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-525-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63304-525-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63304-525-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63304-525-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63304-525-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63304-525-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63304-525-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63304-525-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63304-525-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63304-525-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63304-525-01	`e2bbac7714bc…`	`27bdfed8d636…`

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	Approval date
A075556-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22
A075556-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22
A075556-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22
A075556-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075556-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075556-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075556-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075556-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63304-525-01	2020-01-31	C162847	48780-1	9d75b9d0-4b64-f424-e053-dadaa90a57ce	ENALAPRIL MALEATE TABLETS USP
63304-525-10	2020-01-31	C162847	48780-1	9d75b9d0-4b64-f424-e053-dadaa90a57ce	ENALAPRIL MALEATE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63304-525-01	ENALAPRIL MALEATE	100 in 1 BOTTLE	TABLET	100		2
63304-525-10	ENALAPRIL MALEATE	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-525	ENALAPRIL MALEATE TABLET [RANBAXY PHARMACEUTICALS INC.]	2	Legacy NDC, 2 package rows	20160917_a62de3e5-3508-4d4a-9518-65b8fb23b3be.zip

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	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858810	enalapril maleate 20 MG Oral Tablet	PSN	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858813	enalapril maleate 5 MG Oral Tablet	PSN	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858817	enalapril maleate 10 MG Oral Tablet	SCD	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858810	enalapril maleate 20 MG Oral Tablet	SCD	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2
858813	enalapril maleate 5 MG Oral Tablet	SCD	a62de3e5-3508-4d4a-9518-65b8fb23b3be	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63304-525-01	63304052501	100 in 1 BOTTLE	Historical
63304-525-10	63304052510	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENALAPRIL MALEATE TABLETS USP	Ranbaxy Pharmaceuticals Inc. \| Sun Pharmaceutical Industries Limited \| Ohm Laboratories inc.	2016-04-26	HUMAN PRESCRIPTION DRUG LABEL	2