Orange Book product · Brand (NDA)
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
POTASSIUM CHLORIDE; SODIUM CHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
POTASSIUM CHLORIDE; SODIUM CHLORIDE
Strength
224MG/100ML;900MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 017648
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1989POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019708 · B BRAUN
- 1988POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019686 · OTSUKA ICU MEDCL
- 1982SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERBrand (NDA)
NDA 018722 · B BRAUN
- 2020POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%Generic (ANDA)
ANDA 212347 · FRESENIUS KABI USA
- 2008POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078446 · OTSUKA ICU MEDCL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
