FDA.reportPublic FDA data

MILRINONE LACTATE

Product NDC
0409-0212
11-digit product format
004090212
Labeler code
0409
Product ID
0409-0212_b638edfc-d9db-4247-abd5-1ec3f65a3377
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MILRINONE LACTATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA203280
Marketing category
ANDA
Marketing start
2015-03-31
Substance
MILRINONE LACTATE
Active strength
1 mg/mL
Pharmacologic classes
Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILRINONE LACTATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9K8XR81MO8
Rxcui1791854, 1791859, 1791861

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16d2d4aa-89a2-4b1f-a2c3-337667c79e14Product name420240223
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
470a2760-2c85-45c1-b7d6-7a15ec1b4abfProduct name120210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0212-01MILRINONE LACTATE10 in 1 CARTONINJECTION, SOLUTION107
0409-0212-02MILRINONE LACTATE10 in 1 CARTONINJECTION, SOLUTION107
0409-0212-03MILRINONE LACTATE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION507
0409-0212-03MILRINONE LACTATE1 in 1 CARTONINJECTION, SOLUTION17
0409-0212-10MILRINONE LACTATE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION107
0409-0212-11MILRINONE LACTATE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0212-01ML - Milliliter0409-02120f102dc7-3206-47bb-ae93-159a0004fa5b12015-05-05
0409-0212-02ML - Milliliter0409-021271f86670-5594-480a-9a59-b01b5a9deb2d12015-05-05
0409-0212-03ML - Milliliter0409-0212ddac7245-13c0-41a8-9533-fa74f738ff1b12015-05-05
0409-0212-10ML - Milliliter0409-021215fca4b2-1d23-4f1f-bbd4-4366e1986cdf12015-05-05
0409-0212-11ML - Milliliter0409-02128dd38c29-0ac5-44d8-8374-a7e7fbce10bc12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILRINONE LACTATEACTIVE INGREDIENT9K8XR81MO8MILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]1
MILRINONEACTIVE MOIETYJU9YAX04C7MILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKMILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0212MILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]6Current NDC, Legacy NDC, 6 package rows20210312_813e8ca2-de54-4a7c-a2d2-8bd44396c341.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSN813e8ca2-de54-4a7c-a2d2-8bd44396c3417
1791859milrinone lactate 20 MG in 20 ML InjectionPSN813e8ca2-de54-4a7c-a2d2-8bd44396c3417
1791861milrinone lactate 50 MG in 50 ML InjectionPSN813e8ca2-de54-4a7c-a2d2-8bd44396c3417
179185410 ML milrinone lactate 1 MG/ML InjectionSCD813e8ca2-de54-4a7c-a2d2-8bd44396c3417
179185920 ML milrinone lactate 1 MG/ML InjectionSCD813e8ca2-de54-4a7c-a2d2-8bd44396c3417
179186150 ML milrinone lactate 1 MG/ML InjectionSCD813e8ca2-de54-4a7c-a2d2-8bd44396c3417
1791854milrinone lactate 10 MG per 10 ML InjectionSY813e8ca2-de54-4a7c-a2d2-8bd44396c3417
1791859milrinone lactate 20 MG per 20 ML InjectionSY813e8ca2-de54-4a7c-a2d2-8bd44396c3417
1791861milrinone lactate 50 MG per 50 ML InjectionSY813e8ca2-de54-4a7c-a2d2-8bd44396c3417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-0212-010040902120110 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-0212-10) 2015-04-010000-00-00NoNoCurrent
0409-0212-020040902120210 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-0212-11) 2015-04-010000-00-00NoNoCurrent
0409-0212-03004090212031 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-03) / 50 mL in 1 VIAL, SINGLE-DOSE2015-03-310000-00-00NoNoCurrent
0409-0212-100040902121010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0409-0212-110040902121120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical