Milrinone Lactate

Product NDC: 42677-338
11-digit product format: 426770338
Labeler code: 42677
Product ID: 42677-338_541eb7f5-0e0f-03ab-e063-6294a90a86e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Milrinone Lactate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Shandong New Time Pharmaceutical Co., Ltd.
Application: ANDA216373
Marketing category: ANDA
Marketing start: 2025-06-05
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216373-001	MILRINONE LACTATE	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2023-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216373-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216373-001	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216373-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216373-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216373-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216373-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216373-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216373-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216373-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216373-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216373-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216373-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216373-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216373-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216373-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216373-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216373-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216373-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216373-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216373-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216373-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216373-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216373-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216373-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216373-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216373-001	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216373-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MILRINONE LACTATE	1 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1791854	Internal RxNorm lookup
1791859	Internal RxNorm lookup
1791861	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
0fdaee3c-2144-4ca7-9868-54d251f468c0	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milrinone Lactate	MILRINONE LACTATE	Mullan Pharmaceutical Inc.	07dddead-22ed-004c-e063-6294a90a76fc	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216373 application number: ANDA216373
Milrinone Lactate	MILRINONE LACTATE	Shandong New Time Pharmaceutical Co., Ltd.	0fdaee3c-2144-4ca7-9868-54d251f468c0	2026-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216373 application number: ANDA216373 ndc (product): 42677-338

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
1791854	milrinone lactate 10 MG in 10 ML Injection	PSN	0fdaee3c-2144-4ca7-9868-54d251f468c0	5
1791859	milrinone lactate 20 MG in 20 ML Injection	PSN	0fdaee3c-2144-4ca7-9868-54d251f468c0	5
1791854	10 ML milrinone lactate 1 MG/ML Injection	SCD	0fdaee3c-2144-4ca7-9868-54d251f468c0	5
1791859	20 ML milrinone lactate 1 MG/ML Injection	SCD	0fdaee3c-2144-4ca7-9868-54d251f468c0	5
1791854	milrinone lactate 10 MG per 10 ML Injection	SY	0fdaee3c-2144-4ca7-9868-54d251f468c0	5
1791859	milrinone lactate 20 MG per 20 ML Injection	SY	0fdaee3c-2144-4ca7-9868-54d251f468c0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42677-338-01	42677033801	1 VIAL in 1 CARTON (42677-338-01) / 50 mL in 1 VIAL	1 vial	2025-06-05	No	No	Current
42677-338-10	42677033810	10 VIAL in 1 CARTON (42677-338-10) / 50 mL in 1 VIAL	10 vial	2025-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Milrinone Lactate Injection, USP Rx only	Shandong New Time Pharmaceutical Co., Ltd.	2026-06-13	HUMAN PRESCRIPTION DRUG LABEL	6