Home NDC 0409-7828 Lactated Ringers
Product NDC 0409-7828
11-digit product format 004097828
Labeler code 0409
Product ID 0409-7828_c7d07fd4-5ab8-420c-8ec3-4d8ec88f5d35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE
Dosage form IRRIGANT
Route IRRIGATION
Labeler Hospira, Inc.
Application NDA019416
Marketing category NDA
Marketing start 2005-05-16
Marketing end 2021-08-01
Substance SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
Active strength 600 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-7828-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-7828-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-7828-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-7828-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-7828-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-7828-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-7828-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-7828-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-7828-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-7828-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-7828-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-7828-08 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N019416-001 LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION / IRRIGATION AT RLD, RS 1986-01-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019416-001 AT
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.
Product history page 2 of 2 · 44 observed 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 2022-10-28 04:53 UTC 2022-10 N019416-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION / IRRIGATION AT RLD, RS 1986-01-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019416-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION / IRRIGATION AT RLD, RS 1986-01-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019416-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION / IRRIGATION AT RLD, RS 1986-01-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019416-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION / IRRIGATION AT RLD, RS 1986-01-17 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM CHLORIDE ACTIVE INGREDIENT M4I0D6VV5M LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 SODIUM CHLORIDE ACTIVE INGREDIENT 451W47IQ8X LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 SODIUM LACTATE ACTIVE INGREDIENT TU7HW0W0QT LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 LACTIC ACID ACTIVE MOIETY 33X04XA5AT LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.] 5
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE ICU Medical Inc. b96eb740-749a-4d3a-ae63-b8e3947cad30 2025-10-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 019416 application number: NDA019416
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-7828-08 00409782808 4 POUCH in 1 CASE (0409-7828-08) > 1 BAG in 1 POUCH > 3000 mL in 1 BAG 4 pouch 2005-05-16 2021-08-01 No No Current