ENALAPRILAT

Product NDC
51662-1477
11-digit product format
516621477
Labeler code
51662
Product ID
51662-1477_12044a95-d04f-2681-e063-6394a90af8cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRILAT
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA078687
Marketing category
ANDA
Marketing start
2020-02-01
Substance
ENALAPRILAT
Active strength
1.25 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078687-001ENALAPRILATENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078687-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-233f01610625f2…
2019-09-15 20:21 UTC2019-09A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2008-12-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078687-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2008-12-23e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078687-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078687-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078687-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078687-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078687-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078687-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078687-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078687-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078687-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078687-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078687-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078687-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078687-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078687-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078687-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078687-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078687-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078687-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078687-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078687-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078687-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078687-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078687-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078687-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078687-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078687-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078687-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078687-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078687-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078687-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078687-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078687-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078687-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078687-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078687-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078687-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078687-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078687-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078687-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078687-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
ENALAPRILAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRILAT1.25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GV0O7ES0R3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1729200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d88f915-13dd-5463-e053-2a95a90a09bfAvailable 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
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1477-1ENALAPRILAT1 mL in 1 VIALINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1477ENALAPRILAT INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20240224_9d88f915-13dd-5463-e053-2a95a90a09bf.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENALAPRILATENALAPRILATHF Acquisition Co LLC, DBA HealthFirst9d88f915-13dd-5463-e053-2a95a90a09bf2024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078687
application number: ANDA078687
ndc (product): 51662-1477
EnalaprilatENALAPRILATHikma Pharmaceuticals USA Inc.eabae489-e254-4987-ab90-7cda20a6f8562024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078687
application number: ANDA078687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729200enalaprilat 1.25 MG in 1 ML InjectionPSN9d88f915-13dd-5463-e053-2a95a90a09bf3
17292001 ML enalaprilat 1.25 MG/ML InjectionSCD9d88f915-13dd-5463-e053-2a95a90a09bf3
1729200enalaprilat 1.25 MG per 1 ML InjectionSY9d88f915-13dd-5463-e053-2a95a90a09bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1477-1516621477011 mL in 1 VIAL (51662-1477-1) 1 ml2020-02-010000-00-00NoNoCurrent