Enalapril Maleate

Product NDC
67046-0798
11-digit product format
670460798
Labeler code
67046
Product ID
67046-0798_508a583c-26e6-e226-e063-6394a90a8154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA213273
Marketing category
ANDA
Marketing start
2026-04-28
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
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-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 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2022-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-002ENALAPRIL MALEATE5MGTABLET / ORALAB2022-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-003ENALAPRIL MALEATE10MGTABLET / ORALAB2022-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-004ENALAPRIL MALEATE20MGTABLET / ORALAB2022-07-07d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213273-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Enalapril Maleate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE10 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
508a58fa-9f66-e984-e063-6394a90a296aAvailable 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
67046-0798-3Enalapril Maleate30 in 1 BLISTER PACKTABLET301

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.1b464099-491d-473b-836e-9d86b2b1eeec2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.e47afc0d-afc4-4972-a28a-5d3c640390ab2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATESt. Mary's Medical Park Pharmacyed266486-e4a5-9dd1-e053-2a95a90a80d32026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATECoupler LLC508a58fa-9f66-e984-e063-6394a90a296a2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
ndc (product): 67046-0798
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuticals Inc.5596ba00-4a1c-4503-99db-3a9617ed17c02026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuicals Inc.898b36d6-320f-4d6c-9734-0be8363dc3d72026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuticals Inc.9e277302-6e6c-4a95-8f25-aaff64fb0b822026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATENuCare Pharmaceuticals, Inc.315baaa6-512c-f27b-e063-6294a90a2c912026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2a8ca159-c4c7-468a-bcc2-d1b879ea2c7e2026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATESolco Healthcare US, LLC0c829189-fba2-48f8-a23f-d5471a0345f62026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.5118eb9f-1466-4318-b17e-cf5898edbeef2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.a5c6e64c-a3ed-44f2-83e7-f4b62b6cd6222025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackec6c8c65-b438-40e3-9eb3-665d939abbdb2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d62025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack4f56955c-fc61-49ad-b42f-ff9d3386af6a2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.fe303f6a-4a9f-259e-e053-6394a90af16b2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.cbaaa849-0f9d-4294-b122-090ff17fdcc72025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATENuCare Pharmaceuticals,Inc.fd013f06-3456-c178-e053-6294a90a6bd92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATENuCare Pharmaceuticals,Inc.0b3dbe11-ff75-cb98-e063-6294a90ad2e92025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273
Enalapril MaleateENALAPRIL MALEATECoupler LLC2cc892e2-1d91-e52a-e063-6394a90a66492025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213273
application number: ANDA213273

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN508a58fa-9f66-e984-e063-6394a90a296a1
858817enalapril maleate 10 MG Oral TabletSCD508a58fa-9f66-e984-e063-6394a90a296a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0798-36704607980330 TABLET in 1 BLISTER PACK (67046-0798-3) 30 tablet2026-04-28NoNoCurrent