Home NDC 42677-313 Milrinone Lactate
Product NDC 42677-313
11-digit product format 426770313
Labeler code 42677
Product ID 42677-313_47b2ea09-87c3-2314-e063-6294a90a58b8
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 2023-02-28
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 42 .
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 RLD / RS Approval date Source SHA-256 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# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42677-313-01 Milrinone Lactate 10 mL in 1 VIAL INJECTION, SOLUTION 10 5 42677-313-10 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 42677-313 MILRINONE LACTATE INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] 4 Current NDC, 2 package rows 20241127_0fdaee3c-2144-4ca7-9868-54d251f468c0.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42677-313-01 42677031301 10 mL in 1 VIAL 10 ml Historical 42677-313-10 42677031310 10 VIAL in 1 CARTON (42677-313-10) / 10 mL in 1 VIAL (42677-313-01) 10 vial 2023-03-01 No No Current