Home NDC 83301-0017-2 Milrinone Lactate
Product NDC 83301-0017
Requested package NDC 83301-0017-2
11-digit product format 833010017
Labeler code 83301
Product ID 83301-0017_2bc91e0d-da13-e864-e063-6394a90a4c0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Milrinone Lactate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mullan Pharmaceutical Inc.
Application ANDA216373
Marketing category ANDA
Marketing start 2023-09-18
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83301-0017 83301-0017-2 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 2026-02-19 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 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791854 Internal RxNorm lookup 1791859 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 83301-0017-1 Milrinone Lactate 1 mL in 1 VIAL INJECTION, SOLUTION 1 4 83301-0017-2 Milrinone Lactate 10 in 1 CARTON INJECTION, SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83301-0017 MILRINONE LACTATE INJECTION, SOLUTION [MULLAN PHARMACEUTICAL INC.] 4 Current NDC, 2 package rows 20250119_07dddead-22ed-004c-e063-6294a90a76fc.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 83301-0017-2 83301001702 10 VIAL in 1 CARTON (83301-0017-2) / 1 mL in 1 VIAL (83301-0017-1) 10 vial 2023-09-18 No No Current