Enalapril Maleate

Product NDC: 50090-5976
Requested package NDC: 50090-5976-1
11-digit product format: 500905976
Labeler code: 50090
Product ID: 50090-5976_185ec7cb-acb2-4418-bfc8-8a2aed96ff38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: enalapril maleate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075459
Marketing category: ANDA
Marketing start: 2015-08-06
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: 2023-12-31
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	50090-5976	50090-5976-1	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075459-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB		2000-08-22
A075459-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB		2000-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075459-001	AB
A075459-002	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 3 · 84 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	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075459-001	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075459-002	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A075459-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075459-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075459-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075459-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075459-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075459-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075459-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075459-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075459-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075459-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075459-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075459-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075459-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075459-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075459-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075459-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075459-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075459-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075459-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075459-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075459-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075459-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075459-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075459-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075459-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075459-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075459-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075459-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075459-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075459-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075459-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075459-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075459-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075459-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075459-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075459-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075459-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075459-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075459-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075459-002	AB	1	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5976-0	2024-01-30	C162847	48780-1	1030e365-09f1-111a-e063-dadaa90a10e2	ENALAPRIL MALEATE TABLETS, USP Rx only
50090-5976-1	2024-01-30	C162847	48780-1	1030e365-09f1-111a-e063-dadaa90a10e2	ENALAPRIL MALEATE TABLETS, USP Rx only
50090-5976-4	2024-01-30	C162847	48780-1	1030e365-09f1-111a-e063-dadaa90a10e2	ENALAPRIL MALEATE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5976-0	Enalapril Maleate	30 in 1 BOTTLE	TABLET	30	1
50090-5976-1	Enalapril Maleate	100 in 1 BOTTLE	TABLET	100	1
50090-5976-4	Enalapril Maleate	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5976-0	EA - Each	50090-5976	f8a1b6b0-737b-4324-8cc8-301f6aaa8869	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5976	ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 3 package rows	20220511_3177b98e-e408-4cbe-b470-5087993e767a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril Maleate	ENALAPRIL MALEATE	Northstar RxLLC	e109e7b1-4650-4416-9d89-7c1185d5cf48	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075459 application number: ANDA075459

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	3177b98e-e408-4cbe-b470-5087993e767a	1
858817	enalapril maleate 10 MG Oral Tablet	SCD	3177b98e-e408-4cbe-b470-5087993e767a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5976-1	50090597601	100 TABLET in 1 BOTTLE (50090-5976-1)	100 tablet	2022-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENALAPRIL MALEATE TABLETS, USP Rx only	A-S Medication Solutions	2022-05-10	HUMAN PRESCRIPTION DRUG LABEL	1