FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
43547-548
11-digit product format
435470548
Labeler code
43547
Product ID
43547-548_f83529df-fce5-42ce-bcd4-c7f61f2a0936
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
2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213273-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-07
A213273-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-07
A213273-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-07
A213273-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213273-001AB
A213273-002AB
A213273-003AB
A213273-004AB

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 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-0784e616aacf4f…
2026-08-18 06:07:402026-07A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213273-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213273-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213273-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A213273-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A213273-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213273-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213273-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213273-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213273-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213273-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213273-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213273-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213273-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213273-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213273-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213273-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213273-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213273-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213273-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213273-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213273-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213273-004AB15bbf6a4d5a75…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9O25354EPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858804Internal RxNorm lookup
858810Internal RxNorm lookup
858813Internal RxNorm lookup
858817Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c829189-fba2-48f8-a23f-d5471a0345f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-548-03Enalapril Maleate30 in 1 BOTTLETABLET303
43547-548-09Enalapril Maleate90 in 1 BOTTLETABLET903
43547-548-10Enalapril Maleate100 in 1 BOTTLETABLET1003
43547-548-11Enalapril Maleate1000 in 1 BOTTLETABLET10003
43547-548-50Enalapril Maleate500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-548-10EA - Each43547-54845598cde-72d6-475d-86ab-072ab84e1cc312022-09-12
43547-548-11EA - Each43547-54872dadd39-5d77-4482-ae6c-741f961435f412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-548ENALAPRIL MALEATE TABLET [SOLCO HEALTHCARE US, LLC]2Current NDC, Legacy NDC, 5 package rows20250124_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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsdfc439f7-83f5-4b9e-bbf2-f3d002860be32024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858810enalapril maleate 20 MG Oral TabletPSNec6c8c65-b438-40e3-9eb3-665d939abbdb101
858810enalapril maleate 20 MG Oral TabletSCDec6c8c65-b438-40e3-9eb3-665d939abbdb101
858810enalapril maleate 20 MG Oral TabletPSNe47afc0d-afc4-4972-a28a-5d3c640390ab4
858810enalapril maleate 20 MG Oral TabletPSNcbaaa849-0f9d-4294-b122-090ff17fdcc74
858810enalapril maleate 20 MG Oral TabletPSN9e277302-6e6c-4a95-8f25-aaff64fb0b824
858810enalapril maleate 20 MG Oral TabletSCDe47afc0d-afc4-4972-a28a-5d3c640390ab4
858810enalapril maleate 20 MG Oral TabletSCDcbaaa849-0f9d-4294-b122-090ff17fdcc74
858810enalapril maleate 20 MG Oral TabletSCD9e277302-6e6c-4a95-8f25-aaff64fb0b824
858817enalapril maleate 10 MG Oral TabletPSN0c829189-fba2-48f8-a23f-d5471a0345f63
858804enalapril maleate 2.5 MG Oral TabletPSN0c829189-fba2-48f8-a23f-d5471a0345f63
858810enalapril maleate 20 MG Oral TabletPSN0c829189-fba2-48f8-a23f-d5471a0345f63
858813enalapril maleate 5 MG Oral TabletPSN0c829189-fba2-48f8-a23f-d5471a0345f63
858817enalapril maleate 10 MG Oral TabletSCD0c829189-fba2-48f8-a23f-d5471a0345f63
858804enalapril maleate 2.5 MG Oral TabletSCD0c829189-fba2-48f8-a23f-d5471a0345f63
858810enalapril maleate 20 MG Oral TabletSCD0c829189-fba2-48f8-a23f-d5471a0345f63
858813enalapril maleate 5 MG Oral TabletSCD0c829189-fba2-48f8-a23f-d5471a0345f63
858810enalapril maleate 20 MG Oral TabletPSNfe2dfa84-0276-6603-e053-6394a90af8ee2
858810enalapril maleate 20 MG Oral TabletSCDfe2dfa84-0276-6603-e053-6394a90af8ee2
858810enalapril maleate 20 MG Oral TabletPSN315baaa6-512c-f27b-e063-6294a90a2c911
858810enalapril maleate 20 MG Oral TabletPSNed266486-e4a5-9dd1-e053-2a95a90a80d31
858810enalapril maleate 20 MG Oral TabletSCD315baaa6-512c-f27b-e063-6294a90a2c911
858810enalapril maleate 20 MG Oral TabletSCDed266486-e4a5-9dd1-e053-2a95a90a80d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-548-034354705480330 TABLET in 1 BOTTLE (43547-548-03) 30 tablet2022-07-310000-00-00NoNoCurrent
43547-548-094354705480990 TABLET in 1 BOTTLE (43547-548-09) 90 tablet2022-07-310000-00-00NoNoCurrent
43547-548-1043547054810100 TABLET in 1 BOTTLE (43547-548-10) 100 tablet2022-07-310000-00-00NoNoCurrent
43547-548-11435470548111000 TABLET in 1 BOTTLE (43547-548-11) 1000 tablet2022-07-310000-00-00NoNoCurrent
43547-548-5043547054850500 TABLET in 1 BOTTLE (43547-548-50) 500 tablet2022-07-310000-00-00NoNoCurrent