Milrinone Lactate in Dextrose

Product NDC
0409-1983
11-digit product format
004091983
Labeler code
0409
Product ID
0409-1983_41afad76-bea1-46c5-ab31-84a54b157410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA213585
Marketing category
ANDA
Marketing start
2021-10-04
Substance
MILRINONE LACTATE
Active strength
.2 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

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
A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16
A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213585-001AP
A213585-002AP

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213585-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A213585-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2020-07-16782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213585-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A213585-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213585-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213585-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213585-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213585-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213585-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213585-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213585-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213585-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213585-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213585-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213585-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213585-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213585-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213585-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213585-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213585-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213585-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213585-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213585-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213585-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213585-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213585-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213585-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213585-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213585-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213585-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213585-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213585-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213585-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213585-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213585-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213585-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213585-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213585-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213585-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213585-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213585-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213585-002AP1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Milrinone Lactate in Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILRINONE LACTATE.2 mg/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
5273ea17-6920-4bff-8c5b-20ea531a0423Available 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
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
0409-1983-01Milrinone Lactate in Dextrose200 mL in 1 BAGINJECTION, SOLUTION2002
0409-1983-01Milrinone Lactate in Dextrose1 in 1 POUCHINJECTION, SOLUTION12
0409-1983-10Milrinone Lactate in Dextrose10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1983-01ML - Milliliter0409-1983016e55dc-ca9b-4585-9e50-81028d8d36b212021-11-09
0409-1983-10ML - Milliliter0409-1983414d3187-71ff-4ac0-b946-d7712118199f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1983MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.]2Current NDC, Legacy NDC, 3 package rows20220404_5273ea17-6920-4bff-8c5b-20ea531a0423.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milrinone Lactate in DextroseMILRINONE LACTATE IN DEXTROSEHospira, Inc.5273ea17-6920-4bff-8c5b-20ea531a04232022-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213585
application number: ANDA213585
ndc (product): 0409-1983
Milrinone Lactate in DextroseMILRINONE LACTATEGland Pharma Limited838da14b-c070-4c09-b088-99e7c64d99642021-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213585
application number: ANDA213585
Milrinone Lactate in DextroseMILRINONE LACTATESagent Pharmaceuticalsbb0157d0-a414-43fa-81e0-8c92d717f1b22020-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213585
application number: ANDA213585

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN5273ea17-6920-4bff-8c5b-20ea531a04232
1791842milrinone lactate 40 MG in 200 ML InjectionPSN5273ea17-6920-4bff-8c5b-20ea531a04232
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD5273ea17-6920-4bff-8c5b-20ea531a04232
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD5273ea17-6920-4bff-8c5b-20ea531a04232
1791840milrinone lactate 20 MG per 100 ML InjectionSY5273ea17-6920-4bff-8c5b-20ea531a04232
1791842milrinone lactate 40 MG per 200 ML InjectionSY5273ea17-6920-4bff-8c5b-20ea531a04232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1983-0100409198301200 mL in 1 BAG200 mlHistorical
0409-1983-100040919831010 POUCH in 1 CARTON (0409-1983-10) / 1 BAG in 1 POUCH (0409-1983-01) / 200 mL in 1 BAG10 pouch2021-10-040000-00-00NoNoCurrent