Milrinone Lactate in Dextrose

Product NDC
0143-9718
11-digit product format
001439718
Labeler code
0143
Product ID
0143-9718_e67caf04-0a9c-4638-90a6-c959c9e0b927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090038
Marketing category
ANDA
Marketing start
2010-01-21
Substance
MILRINONE LACTATE
Active strength
200 ug/mL
Pharmacologic classes
Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090038-001MILRINONE LACTATE IN PLASTIC CONTAINERMILRINONE LACTATEEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21
A090038-002MILRINONE LACTATE IN PLASTIC CONTAINERMILRINONE LACTATEEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090038-001AP
A090038-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090038-001MILRINONE LACTATE IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090038-002MILRINONE LACTATE IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2010-01-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090038-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A090038-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090038-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090038-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090038-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090038-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090038-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090038-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090038-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090038-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090038-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090038-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090038-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090038-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090038-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090038-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090038-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090038-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090038-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090038-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090038-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090038-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090038-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090038-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090038-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090038-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090038-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090038-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090038-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090038-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090038-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090038-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090038-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090038-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090038-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090038-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090038-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090038-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090038-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090038-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Milrinone Lactate in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILRINONE LACTATE200 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9K8XR81MO8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1791840Internal RxNorm lookup
1791842Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c2f052b-7ba2-4122-a50b-37ef2a834d61Available on FDA.report

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9718-01Milrinone Lactate in Dextrose200 mL in 1 CONTAINERINJECTION, SOLUTION2008
0143-9718-10Milrinone Lactate in Dextrose10 in 1 PACKAGEINJECTION, SOLUTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9718-01ML - Milliliter0143-97187fe55396-6e1f-44ca-ad45-57242dd9745f12017-03-06
0143-9718-10ML - Milliliter0143-97186f7eb80f-6e52-4c08-9988-89c7d1906a4412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9718MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250311_4c2f052b-7ba2-4122-a50b-37ef2a834d61.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milrinone Lactate in DextroseMILRINONE LACTATE IN DEXTROSEHikma Pharmaceuticals USA Inc.4c2f052b-7ba2-4122-a50b-37ef2a834d612026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090038
application number: ANDA090038
ndc (product): 0143-9718

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791842milrinone lactate 40 MG in 200 ML InjectionPSN4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791840milrinone lactate 20 MG per 100 ML InjectionSY4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791842milrinone lactate 40 MG per 200 ML InjectionSY4c2f052b-7ba2-4122-a50b-37ef2a834d618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9718-0100143971801200 mL in 1 CONTAINER200 mlHistorical
0143-9718-100014397181010 CONTAINER in 1 PACKAGE (0143-9718-10) / 200 mL in 1 CONTAINER (0143-9718-01) 10 container2010-01-210000-00-00NoNoCurrent