ENALAPRILAT

Product NDC
0409-2122
11-digit product format
004092122
Labeler code
0409
Product ID
0409-2122_f468cb85-9046-4202-8df6-b13900edc2f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRILAT
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075458
Marketing category
ANDA
Marketing start
2005-08-24
Marketing end
0000-00-00
Substance
ENALAPRILAT
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-2122DDiscontinued by firm2026-08-17
excluded productproduct0409-2122DDiscontinued by firm2026-08-17
excluded packagepackage0409-21220409-2122-01DDiscontinued by firm2026-08-17
excluded packagepackage0409-21220409-2122-02DDiscontinued by firm2026-08-17
excluded packagepackage0409-21220409-2122-13DDiscontinued by firm2026-08-17
excluded packagepackage0409-21220409-2122-88DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2122-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2122-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2122-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2122-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2122-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2122-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2122-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2122-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2122-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2122-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2122-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2122-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2122-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2122-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2122-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2122-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2122-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2122-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2122-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2122-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2122-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2122-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2122-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2122-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2122-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2122-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2122-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2122-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2122-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2122-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2122-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2122-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2122-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2122-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2122-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2122-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2122-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2122-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2122-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2122-02ad56d346431e…cc804d4bbf1e…

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
A075458-001ENALAPRILATENALAPRILAT1.25MG/MLINJECTABLE / INJECTION2000-08-22

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 06:07:402026-07A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTION2000-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTION2000-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTION2000-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-223f01610625f2…
2019-09-15 20:21 UTC2019-09A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAPRS2000-08-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075458-001ENALAPRILAT1.25MG/MLINJECTABLE / INJECTIONAP2000-08-22e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A075458-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075458-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075458-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075458-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075458-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075458-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075458-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075458-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075458-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075458-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075458-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075458-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075458-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075458-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075458-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075458-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075458-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075458-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075458-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A075458-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075458-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075458-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075458-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A075458-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075458-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075458-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075458-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075458-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075458-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075458-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075458-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075458-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075458-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075458-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075458-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075458-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075458-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075458-001AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2122-01ML - Milliliter0409-2122ebb06247-722b-4c8e-afb4-2132916cbe0a12012-07-24
0409-2122-02ML - Milliliter0409-2122610d73b9-14fe-4007-a6b9-205999e483f212012-07-24
0409-2122-13ML - Milliliter0409-2122cdd2cc51-71e8-4e76-9e5d-1ff37825fdb812012-07-24
0409-2122-88ML - Milliliter0409-21226eec2da6-e36a-4303-be49-f365dad16a4112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRILATACTIVE INGREDIENTGV0O7ES0R3ENALAPRILAT INJECTION, SOLUTION [HOSPIRA, INC.]13
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRILAT INJECTION, SOLUTION [HOSPIRA, INC.]13
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHENALAPRILAT INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XENALAPRILAT INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENALAPRILAT INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RENALAPRILAT INJECTION, SOLUTION [HOSPIRA, INC.]13