Home NDC 0143-9787 Enalaprilat
Product NDC 0143-9787
11-digit product format 001439787
Labeler code 0143
Product ID 0143-9787_bde8c35d-1cf2-42ea-a2a7-c4eb165e6d0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enalaprilat
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA078687
Marketing category ANDA
Marketing start 2008-12-23
Substance ENALAPRILAT DIHYDRATE
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078687-001 ENALAPRILAT ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078687-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2008-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078687-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP RS 2008-12-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Enalaprilat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENALAPRILAT DIHYDRATE 1.25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GV0O7ES0R3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1729200 Internal RxNorm lookup 1729205 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9787-01 Enalaprilat 1 mL in 1 VIAL INJECTION 1 12 0143-9787-10 Enalaprilat 10 in 1 CARTON INJECTION 10 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9787 ENALAPRILAT INJECTION [HIKMA PHARMACEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240105_eabae489-e254-4987-ab90-7cda20a6f856.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9787-01 00143978701 1 mL in 1 VIAL 1 ml Historical 0143-9787-10 00143978710 10 VIAL in 1 CARTON (0143-9787-10) / 1 mL in 1 VIAL (0143-9787-01) 10 vial 2008-12-23 0000-00-00 No No Current