Milrinone Lactate

Product NDC: 55150-287
11-digit product format: 551500287
Labeler code: 55150
Product ID: 55150-287_1c966c02-f3de-40dd-83ec-1bc2a3de2c7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Milrinone Lactate in 5% Dextrose
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA209666
Marketing category: ANDA
Marketing start: 2020-09-03
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP		2020-09-03
A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP		2020-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209666-001	AP
A209666-002	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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209666-001	MILRINONE LACTATE IN DEXTROSE 5%	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209666-002	MILRINONE LACTATE IN DEXTROSE 5%	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE / INJECTION	AP	2020-09-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209666-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209666-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209666-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209666-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209666-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209666-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209666-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209666-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209666-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209666-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209666-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209666-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209666-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209666-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209666-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209666-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209666-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209666-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209666-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209666-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209666-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209666-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209666-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209666-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209666-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209666-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209666-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209666-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209666-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209666-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209666-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209666-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209666-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209666-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209666-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209666-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209666-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209666-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209666-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209666-002	AP	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MILRINONE LACTATE	.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9K8XR81MO8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4e489fab-75bc-4514-9bf2-85b8ed08a1b0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16d2d4aa-89a2-4b1f-a2c3-337667c79e14	Product name	4	20240223
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
470a2760-2c85-45c1-b7d6-7a15ec1b4abf	Product name	1	20210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55150-287-01	Milrinone Lactate	1 in 1 POUCH	INJECTION, SOLUTION	1	5
55150-287-01	Milrinone Lactate	100 mL in 1 BAG	INJECTION, SOLUTION	100	5
55150-287-10	Milrinone Lactate	10 in 1 CARTON	INJECTION, SOLUTION	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-287	MILRINONE LACTATE (MILRINONE LACTATE IN 5% DEXTROSE) INJECTION, SOLUTION [EUGIA US LLC]	5	Current NDC, Legacy NDC, 3 package rows	20230621_4e489fab-75bc-4514-9bf2-85b8ed08a1b0.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milrinone Lactate	MILRINONE LACTATE IN 5% DEXTROSE	Eugia US LLC	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209666 application number: ANDA209666 ndc (product): 55150-287

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9K8XR81MO8	MILRINONE LACTATE	100286-97-3	MILRINONE LACTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791840	milrinone lactate 20 MG in 100 ML Injection	PSN	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	5
1791842	milrinone lactate 40 MG in 200 ML Injection	PSN	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	5
1791840	100 ML milrinone lactate 0.2 MG/ML Injection	SCD	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	5
1791842	200 ML milrinone lactate 0.2 MG/ML Injection	SCD	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	5
1791840	milrinone lactate 20 MG per 100 ML Injection	SY	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	5
1791842	milrinone lactate 40 MG per 200 ML Injection	SY	4e489fab-75bc-4514-9bf2-85b8ed08a1b0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-287-01	55150028701	1 in 1 POUCH						Historical
55150-287-10	55150028710	10 POUCH in 1 CARTON (55150-287-10) / 1 BAG in 1 POUCH (55150-287-01) / 100 mL in 1 BAG	10 pouch	2020-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Milrinone Lactate in 5% Dextrose Injection Rx only	Eugia US LLC \| Eugia Pharma Specialities Limited	2023-02-01	Human Prescription Drug Label	5