Orange Book product · Brand (NDA)
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
At a glance
Oct 17, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 17, 1988
38 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Strength
20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019685
Product number
007
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.
- 1988DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019634 · B BRAUN
- 1985POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019367 · BAXTER HLTHCARE
- —DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 017608 · OTSUKA ICU MEDCL
- —DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 017510 · B BRAUN
- —DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 018499 · MILES
- —LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 016679 · BAXTER HLTHCARE
- 2022DEXTROSE 5% AND LACTATED RINGER'SGeneric (ANDA)
ANDA 210332 · FRESENIUS KABI USA
- 2021POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 211428 · FRESENIUS KABI USA
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.
