Home NDC 83301-0018 Milrinone Lactate
Product NDC 83301-0018
11-digit product format 833010018
Labeler code 83301
Product ID 83301-0018_579eba00-979d-93a1-e063-6294a90abb9d
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 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 RLD / RS 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# 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.
DailyMed Product Concepts# 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 Marketing start Sample Exclude flag Status 83301-0018-1 83301001801 1 VIAL, SINGLE-DOSE in 1 CARTON (83301-0018-1) / 1 mL in 1 VIAL, SINGLE-DOSE 2026-08-16 No No Current