Home NDC 71288-200 Milrinone Lactate
Product NDC 71288-200
11-digit product format 712880200
Labeler code 71288
Product ID 71288-200_9fb02532-b43c-40c3-adf1-f5071a415e05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Milrinone Lactate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA211671
Marketing category ANDA
Marketing start 2020-03-24
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 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 A211671-001 MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211671-001 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 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211671-001 MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2020-03-24 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 · 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 71288-200-10 Milrinone Lactate 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 4 71288-200-11 Milrinone Lactate 10 in 1 CARTON INJECTION, SOLUTION 10 4 71288-200-20 Milrinone Lactate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 4 71288-200-21 Milrinone Lactate 10 in 1 CARTON INJECTION, SOLUTION 10 4 71288-200-50 Milrinone Lactate 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 4 71288-200-50 Milrinone Lactate 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-200 MILRINONE LACTATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 6 package rows 20220115_6c6b69f9-e229-4a93-a108-9eafdab614f0.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71288-200-10 71288020010 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 71288-200-11 71288020011 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-200-10) 2020-03-24 0000-00-00 No No Current 71288-200-20 71288020020 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 71288-200-21 71288020021 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-200-20) 2020-03-24 0000-00-00 No No Current 71288-200-50 71288020050 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-50) / 50 mL in 1 VIAL, SINGLE-DOSE 2020-03-24 0000-00-00 No No Current