Enalapril maleate

Product NDC: 52536-401
11-digit product format: 525360401
Labeler code: 52536
Product ID: 52536-401_461e14b2-890d-011c-e063-6294a90a0d4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enalapril maleate
Dosage form: SOLUTION
Route: ORAL
Labeler: Wilshire Pharmaceuticals, Inc.
Application: NDA208686
Marketing category: NDA
Marketing start: 2024-04-08
Substance: ENALAPRIL MALEATE
Active strength: 1 mg/mL
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208686-001	EPANED	ENALAPRIL MALEATE	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208686-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208686-001	10039745	2036-03-25		Drug product	2018-08-23
N208686-001	10154987	2036-03-25	U-1723		2019-01-04
N208686-001	10154987	2036-03-25	U-185		2019-01-04
N208686-001	10154987	2036-03-25	U-1892		2019-01-04
N208686-001	10154987	2036-03-25	U-3		2019-01-04
N208686-001	10154987	2036-03-25	U-71		2019-01-04
N208686-001	10772868	2036-03-25		Drug product	2020-09-23
N208686-001	10786482	2036-03-25		Drug product	2020-10-08
N208686-001	11040023	2036-03-25		Drug product	2021-06-25
N208686-001	11141405	2036-03-25		Drug product	2021-10-19
N208686-001	11173141	2036-03-25		Drug product	2022-02-08
N208686-001	9669008	2036-03-25		Drug product	2017-06-09
N208686-001	9808442	2036-03-25	U-1723		2017-11-20
N208686-001	9808442	2036-03-25	U-185		2017-11-20
N208686-001	9808442	2036-03-25	U-1892		2017-11-20
N208686-001	9808442	2036-03-25	U-3		2017-11-20
N208686-001	9808442	2036-03-25	U-71		2017-11-20

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL		RLD, RS	2016-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208686-001	EPANED	1MG/ML	SOLUTION / ORAL	AB	RLD, RS	2016-09-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N208686-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208686-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208686-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208686-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208686-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208686-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208686-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208686-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208686-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208686-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208686-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208686-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208686-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208686-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208686-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208686-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208686-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208686-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208686-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208686-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208686-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208686-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208686-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208686-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208686-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208686-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208686-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208686-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208686-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208686-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208686-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208686-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208686-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208686-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208686-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 697 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208686-001	10039745	2036-03-25		Drug product	2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10154987	2036-03-25	U-3		2019-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10154987	2036-03-25	U-1892		2019-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10154987	2036-03-25	U-185		2019-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10154987	2036-03-25	U-71		2019-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10154987	2036-03-25	U-1723		2019-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10772868	2036-03-25		Drug product	2020-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	10786482	2036-03-25		Drug product	2020-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	11040023	2036-03-25		Drug product	2021-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	11141405	2036-03-25		Drug product	2021-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	11173141	2036-03-25		Drug product	2022-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	9669008	2036-03-25		Drug product	2017-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	9808442	2036-03-25	U-71		2017-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	9808442	2036-03-25	U-1723		2017-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	9808442	2036-03-25	U-185		2017-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	9808442	2036-03-25	U-1892		2017-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208686-001	9808442	2036-03-25	U-3		2017-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208686-001	10039745	2036-03-25		Drug product	2018-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-3		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-1892		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-185		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-71		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10154987	2036-03-25	U-1723		2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10772868	2036-03-25		Drug product	2020-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	10786482	2036-03-25		Drug product	2020-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	11040023	2036-03-25		Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	11141405	2036-03-25		Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	11173141	2036-03-25		Drug product	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9669008	2036-03-25		Drug product	2017-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-71		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-1723		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-185		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-1892		2017-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208686-001	9808442	2036-03-25	U-3		2017-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10039745	2036-03-25		Drug product	2018-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-3		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-1892		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-185		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-71		2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208686-001	10154987	2036-03-25	U-1723		2019-01-04	`011fe1cb6892…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENALAPRIL MALEATE	1 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1435624	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
c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	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
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
52536-401-01	Enalapril maleate	1 in 1 CARTON	SOLUTION	1		2
52536-401-01	Enalapril maleate	150 mL in 1 BOTTLE	SOLUTION	150		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52536-401-01	ML - Milliliter	52536-401	f082d63b-9d07-47a1-9cd6-8dbb6eee87cd	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52536-401	ENALAPRIL MALEATE SOLUTION [WILSHIRE PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20240413_c7934b45-eb6b-44c1-bd2c-ef0fa10850c1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril maleate	ENALAPRIL MALEATE	Wilshire Pharmaceuticals, Inc.	c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208686 application number: NDA208686 ndc (product): 52536-401
Epaned	ENALAPRIL MALEATE	Azurity Pharmaceuticals, Inc.	e6dbda02-779e-420c-893d-d0fea09432be	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208686 application number: NDA208686

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
1435624	enalapril maleate 1 MG in 1 mL Oral Solution	PSN	c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	2
1435624	enalapril maleate 1 MG/ML Oral Solution	SCD	c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	2
1435624	enalapril maleate 1 MG per 1 ML Oral Solution	SY	c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52536-401-01	52536040101	1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE	1 bottle	2024-04-08	No	No	Current