ENALAPRIL MALEATE

Product NDC: 64980-688
11-digit product format: 649800688
Labeler code: 64980
Product ID: 64980-688_6f4c73c0-8b68-485d-87f6-cd77746aada8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENALAPRIL MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA218531
Marketing category: ANDA
Marketing start: 2025-02-24
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: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A218531-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19
A218531-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19
A218531-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19
A218531-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A218531-001	AB
A218531-002	AB
A218531-003	AB
A218531-004	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 2 · 44 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	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218531-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2024-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218531-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2024-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218531-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2024-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218531-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2024-09-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A218531-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218531-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218531-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218531-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218531-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218531-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218531-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218531-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218531-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218531-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218531-004	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218531-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218531-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218531-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218531-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218531-004	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	20 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858804	Internal RxNorm lookup
858810	Internal RxNorm lookup
858813	Internal RxNorm lookup
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
71e9fff3-7283-437e-b107-72fc16f09989	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
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
64980-688-01	ENALAPRIL MALEATE	100 in 1 BOTTLE	TABLET	100		3
64980-688-10	ENALAPRIL MALEATE	1000 in 1 BOTTLE	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-688-01	EA - Each	64980-688	acadba92-3ac1-4761-b8f6-b5577e30814e	1	2025-05-14
64980-688-10	EA - Each	64980-688	9f8eb5f3-a816-40f8-bb40-33c930230671	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-688	ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [RISING PHARMA HOLDINGS, INC.]	1	Current NDC, 2 package rows	20250227_71e9fff3-7283-437e-b107-72fc16f09989.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 · 5 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	fa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	b31372f7-cda3-4ead-a481-4cde62e843fd	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	eee8633b-9d9e-453d-8c6b-8b13c94d2f58	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Bryant Ranch Prepack	c1e4cd79-ece5-432c-bd3a-ed4633ccec70	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Rising Pharma Holdings, Inc.	71e9fff3-7283-437e-b107-72fc16f09989	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218531 application number: ANDA218531 ndc (product): 64980-688

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	71e9fff3-7283-437e-b107-72fc16f09989	3
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	71e9fff3-7283-437e-b107-72fc16f09989	3
858810	enalapril maleate 20 MG Oral Tablet	PSN	71e9fff3-7283-437e-b107-72fc16f09989	3
858813	enalapril maleate 5 MG Oral Tablet	PSN	71e9fff3-7283-437e-b107-72fc16f09989	3
858817	enalapril maleate 10 MG Oral Tablet	SCD	71e9fff3-7283-437e-b107-72fc16f09989	3
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	71e9fff3-7283-437e-b107-72fc16f09989	3
858810	enalapril maleate 20 MG Oral Tablet	SCD	71e9fff3-7283-437e-b107-72fc16f09989	3
858813	enalapril maleate 5 MG Oral Tablet	SCD	71e9fff3-7283-437e-b107-72fc16f09989	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64980-688-01	64980068801	100 TABLET in 1 BOTTLE (64980-688-01)	100 tablet	2025-02-24	No	No	Current
64980-688-10	64980068810	1000 TABLET in 1 BOTTLE (64980-688-10)	1000 tablet	2025-02-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enalapril Maleate Tablets, USP	Preferred Pharmaceuticals Inc.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	1
Enalapril Maleate Tablets, USP	Rising Pharma Holdings, Inc. \| Unique Pharmaceutical Laboratories	2025-10-03	HUMAN PRESCRIPTION DRUG LABEL	3