FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiGV0O7ES0R3
Rxcui1729200, 1729205

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
43598-078-11Enalaprilat1 mL in 1 VIALINJECTION16
43598-078-58Enalaprilat10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-078-11ML - Milliliter43598-0781e06fb0c-c38b-420c-a54a-b87e2874e24112023-07-06
43598-078-58ML - Milliliter43598-078714c7bd4-1913-4a53-afaa-7393885b923012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-078ENALAPRILAT INJECTION [DR. REDDYS LABORATORIES INC]6Current NDC, 2 package rows20240608_5d398da1-020c-ccb1-a775-ce8e0b29d621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729200enalaprilat 1.25 MG in 1 ML InjectionPSN5d398da1-020c-ccb1-a775-ce8e0b29d6216
1729205enalaprilat 2.5 MG in 2 ML InjectionPSN5d398da1-020c-ccb1-a775-ce8e0b29d6216
17292001 ML enalaprilat 1.25 MG/ML InjectionSCD5d398da1-020c-ccb1-a775-ce8e0b29d6216
17292052 ML enalaprilat 1.25 MG/ML InjectionSCD5d398da1-020c-ccb1-a775-ce8e0b29d6216
1729200enalaprilat 1.25 MG per 1 ML InjectionSY5d398da1-020c-ccb1-a775-ce8e0b29d6216
1729205enalaprilat 2.5 MG per 2 ML InjectionSY5d398da1-020c-ccb1-a775-ce8e0b29d6216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-078-11435980078111 mL in 1 VIAL1 mlHistorical
43598-078-584359800785810 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) 10 vial2023-06-06NoNoHistorical