Enalapril Maleate

Product NDC: 43547-548
11-digit product format: 435470548
Labeler code: 43547
Product ID: 43547-548_c3c8f70a-800d-40f1-8f11-0cc49c51d67c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA213273
Marketing category: ANDA
Marketing start: 2022-07-31
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: 2026-12-31
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
A213273-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07
A213273-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07
A213273-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07
A213273-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213273-001	AB
A213273-002	AB
A213273-003	AB
A213273-004	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 3 · 112 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	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2022-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2022-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2022-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2022-07-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 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	A213273-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213273-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213273-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213273-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213273-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213273-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213273-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213273-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213273-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213273-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213273-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213273-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213273-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213273-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213273-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213273-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213273-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213273-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213273-004	AB	1	`d8e5a09893c0…`

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
0c829189-fba2-48f8-a23f-d5471a0345f6	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	SPL version
43547-548-03	Enalapril Maleate	30 in 1 BOTTLE	TABLET	30	3
43547-548-09	Enalapril Maleate	90 in 1 BOTTLE	TABLET	90	3
43547-548-10	Enalapril Maleate	100 in 1 BOTTLE	TABLET	100	3
43547-548-11	Enalapril Maleate	1000 in 1 BOTTLE	TABLET	1000	3
43547-548-50	Enalapril Maleate	500 in 1 BOTTLE	TABLET	500	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-548-10	EA - Each	43547-548	45598cde-72d6-475d-86ab-072ab84e1cc3	1	2022-09-12
43547-548-11	EA - Each	43547-548	72dadd39-5d77-4482-ae6c-741f961435f4	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-548	ENALAPRIL MALEATE TABLET [SOLCO HEALTHCARE US, LLC]	2	Current NDC, Legacy NDC, 5 package rows	20250124_0c829189-fba2-48f8-a23f-d5471a0345f6.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	1b464099-491d-473b-836e-9d86b2b1eeec	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	e47afc0d-afc4-4972-a28a-5d3c640390ab	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	St. Mary's Medical Park Pharmacy	ed266486-e4a5-9dd1-e053-2a95a90a80d3	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Coupler LLC	508a58fa-9f66-e984-e063-6394a90a296a	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	5596ba00-4a1c-4503-99db-3a9617ed17c0	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Preferred Pharmaceuicals Inc.	898b36d6-320f-4d6c-9734-0be8363dc3d7	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	9e277302-6e6c-4a95-8f25-aaff64fb0b82	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals, Inc.	315baaa6-512c-f27b-e063-6294a90a2c91	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2a8ca159-c4c7-468a-bcc2-d1b879ea2c7e	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Solco Healthcare US, LLC	0c829189-fba2-48f8-a23f-d5471a0345f6	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273 ndc (product): 43547-548
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	5118eb9f-1466-4318-b17e-cf5898edbeef	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	a5c6e64c-a3ed-44f2-83e7-f4b62b6cd622	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	ec6c8c65-b438-40e3-9eb3-665d939abbdb	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	4f56955c-fc61-49ad-b42f-ff9d3386af6a	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	PD-Rx Pharmaceuticals, Inc.	fe303f6a-4a9f-259e-e053-6394a90af16b	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	PD-Rx Pharmaceuticals, Inc.	cbaaa849-0f9d-4294-b122-090ff17fdcc7	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	fd013f06-3456-c178-e053-6294a90a6bd9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	0b3dbe11-ff75-cb98-e063-6294a90ad2e9	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273
Enalapril Maleate	ENALAPRIL MALEATE	Coupler LLC	2cc892e2-1d91-e52a-e063-6394a90a6649	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213273 application number: ANDA213273

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
858810	enalapril maleate 20 MG Oral Tablet	PSN	ec6c8c65-b438-40e3-9eb3-665d939abbdb	101
858810	enalapril maleate 20 MG Oral Tablet	SCD	ec6c8c65-b438-40e3-9eb3-665d939abbdb	101
858810	enalapril maleate 20 MG Oral Tablet	PSN	e47afc0d-afc4-4972-a28a-5d3c640390ab	4
858810	enalapril maleate 20 MG Oral Tablet	PSN	cbaaa849-0f9d-4294-b122-090ff17fdcc7	4
858810	enalapril maleate 20 MG Oral Tablet	PSN	9e277302-6e6c-4a95-8f25-aaff64fb0b82	4
858810	enalapril maleate 20 MG Oral Tablet	SCD	e47afc0d-afc4-4972-a28a-5d3c640390ab	4
858810	enalapril maleate 20 MG Oral Tablet	SCD	cbaaa849-0f9d-4294-b122-090ff17fdcc7	4
858810	enalapril maleate 20 MG Oral Tablet	SCD	9e277302-6e6c-4a95-8f25-aaff64fb0b82	4
858817	enalapril maleate 10 MG Oral Tablet	PSN	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858804	enalapril maleate 2.5 MG Oral Tablet	PSN	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858810	enalapril maleate 20 MG Oral Tablet	PSN	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858813	enalapril maleate 5 MG Oral Tablet	PSN	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858817	enalapril maleate 10 MG Oral Tablet	SCD	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858804	enalapril maleate 2.5 MG Oral Tablet	SCD	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858810	enalapril maleate 20 MG Oral Tablet	SCD	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858813	enalapril maleate 5 MG Oral Tablet	SCD	0c829189-fba2-48f8-a23f-d5471a0345f6	3
858810	enalapril maleate 20 MG Oral Tablet	PSN	fe2dfa84-0276-6603-e053-6394a90af8ee	2
858810	enalapril maleate 20 MG Oral Tablet	SCD	fe2dfa84-0276-6603-e053-6394a90af8ee	2
858810	enalapril maleate 20 MG Oral Tablet	PSN	315baaa6-512c-f27b-e063-6294a90a2c91	1
858810	enalapril maleate 20 MG Oral Tablet	PSN	ed266486-e4a5-9dd1-e053-2a95a90a80d3	1
858810	enalapril maleate 20 MG Oral Tablet	SCD	315baaa6-512c-f27b-e063-6294a90a2c91	1
858810	enalapril maleate 20 MG Oral Tablet	SCD	ed266486-e4a5-9dd1-e053-2a95a90a80d3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-548-03	43547054803	30 TABLET in 1 BOTTLE (43547-548-03)	30 tablet	2022-07-31	0000-00-00	No	No	Current
43547-548-09	43547054809	90 TABLET in 1 BOTTLE (43547-548-09)	90 tablet	2022-07-31	0000-00-00	No	No	Current
43547-548-10	43547054810	100 TABLET in 1 BOTTLE (43547-548-10)	100 tablet	2022-07-31	0000-00-00	No	No	Current
43547-548-11	43547054811	1000 TABLET in 1 BOTTLE (43547-548-11)	1000 tablet	2022-07-31	0000-00-00	No	No	Current
43547-548-50	43547054850	500 TABLET in 1 BOTTLE (43547-548-50)	500 tablet	2022-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENALAPRIL MALEATE TABLETS Rx only	REMEDYREPACK INC.	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	6
ENALAPRIL MALEATE TABLETS Rx only	St. Mary's Medical Park Pharmacy	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	2
ENALAPRIL MALEATE TABLETS Rx only	Preferred Pharmaceuticals Inc.	2026-04-10	HUMAN PRESCRIPTION DRUG LABEL	4
ENALAPRIL MALEATE TABLETS Rx only	NuCare Pharmaceuticals, Inc.	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	2
ENALAPRIL MALEATE TABLETS Rx only	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co., LTD \| Zhejiang Huahai Pharmaceutical Technology Co., Ltd.	2026-01-31	HUMAN PRESCRIPTION DRUG LABEL	4
ENALAPRIL MALEATE TABLETS Rx only	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	101
ENALAPRIL MALEATE TABLETS Rx only	PD-Rx Pharmaceuticals, Inc.	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	4
ENALAPRIL MALEATE TABLETS Rx only	NuCare Pharmaceuticals,Inc.	2025-01-02	HUMAN PRESCRIPTION DRUG LABEL	2