Orange Book product · Brand (NDA)
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Strength
20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 017608
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1988POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERBrand (NDA)
NDA 019685 · OTSUKA ICU MEDCL
- 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% 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.
