Physiosol

Product NDC
0409-6141
11-digit product format
004096141
Labeler code
0409
Product ID
0409-6141_f9023ddc-a430-47a3-a7a9-ede847e8b974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
Hospira, Inc.
Application
NDA017637
Marketing category
NDA
Marketing start
2011-02-11
Marketing end
2021-08-01
Substance
SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
Active strength
526 mg/100mL; 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],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],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6141-03ML - Milliliter0409-61415ed581ec-7cd8-42e4-8d35-1c912222043212012-07-24
0409-6141-09ML - Milliliter0409-614182e48668-77ba-4097-aa6d-02634216cdcb12012-07-24
0409-6141-22ML - Milliliter0409-61412219a7c8-c08d-479c-aa98-3bc47e6ee27012012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-6141-030040961410324 BOTTLE, PLASTIC in 1 CASE (0409-6141-03) > 500 mL in 1 BOTTLE, PLASTIC2011-02-112021-08-01NoNoCurrent
0409-6141-090040961410912 BOTTLE, PLASTIC in 1 CASE (0409-6141-09) > 1000 mL in 1 BOTTLE, PLASTIC2011-02-112021-08-01NoNoCurrent
0409-6141-220040961412224 BOTTLE, PLASTIC in 1 CASE (0409-6141-22) > 250 mL in 1 BOTTLE, PLASTIC2011-02-112021-08-01NoNoCurrent