Home NDC 43598-078 Enalaprilat
Product NDC 43598-078
11-digit product format 435980078
Labeler code 43598
Product ID 43598-078_d20e2c0a-b04d-5e4a-a28b-442e0a77f3b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enalaprilat
Dosage form INJECTION
Route INTRAVENOUS
Labeler Dr. Reddys Laboratories Inc
Application ANDA075578
Marketing category ANDA
Marketing start 2023-06-06
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075578-001 ENALAPRILAT ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075578-001 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 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION AP 2000-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075578-001 ENALAPRILAT 1.25MG/ML INJECTABLE / INJECTION 2000-08-22 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Enalaprilat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENALAPRILAT 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 43598-078-11 Enalaprilat 1 mL in 1 VIAL INJECTION 1 6 43598-078-58 Enalaprilat 10 in 1 CARTON INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-078 ENALAPRILAT INJECTION [DR. REDDYS LABORATORIES INC] 6 Current NDC, 2 package rows 20240608_5d398da1-020c-ccb1-a775-ce8e0b29d621.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-078-11 43598007811 1 mL in 1 VIAL 1 ml Historical 43598-078-58 43598007858 10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) 10 vial 2023-06-06 No No Current