Home NDC 70069-872 Milrinone Lactate in 5% Dextrose
Product NDC 70069-872
11-digit product format 700690872
Labeler code 70069
Product ID 70069-872_27a19fc1-5e18-44e1-957d-d90f18dedc54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Milrinone Lactate in 5% Dextrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA219170
Marketing category ANDA
Marketing start 2026-03-25
Substance MILRINONE LACTATE
Active strength .2 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219170-001 MILRINONE LACTATE IN DEXTROSE 5% MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 A219170-002 MILRINONE LACTATE IN DEXTROSE 5% MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A219170-001 MILRINONE LACTATE IN DEXTROSE 5% EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219170-002 MILRINONE LACTATE IN DEXTROSE 5% EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219170-001 MILRINONE LACTATE IN DEXTROSE 5% EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219170-002 MILRINONE LACTATE IN DEXTROSE 5% EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219170-001 MILRINONE LACTATE IN DEXTROSE 5% EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219170-002 MILRINONE LACTATE IN DEXTROSE 5% EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219170-001 MILRINONE LACTATE IN DEXTROSE 5% EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219170-002 MILRINONE LACTATE IN DEXTROSE 5% EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE / INJECTION AP 2025-09-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Milrinone Lactate in 5% Dextrose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MILRINONE LACTATE .2 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 1791840 Internal RxNorm lookup 1791842 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 70069-872-01 Milrinone Lactate in 5% Dextrose 100 mL in 1 BAG INJECTION, SOLUTION 100 1 70069-872-01 Milrinone Lactate in 5% Dextrose 1 in 1 POUCH INJECTION, SOLUTION 1 1 70069-872-10 Milrinone Lactate in 5% Dextrose 10 in 1 CASE INJECTION, SOLUTION 10 1
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 70069-872-01 70069087201 100 mL in 1 BAG 100 ml Historical 70069-872-10 70069087210 10 POUCH in 1 CASE (70069-872-10) / 1 BAG in 1 POUCH (70069-872-01) / 100 mL in 1 BAG 10 pouch 2026-03-25 No No Current