Orange Book product · Brand (NDA)
SODIUM CHLORIDE 0.9%
SODIUM CHLORIDE
At a glance
Jan 06, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 06, 2012
14 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM CHLORIDE
Strength
45MG/5ML (9MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 202832
Product number
005
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.
- 2006SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 021569 · LIEBEL-FLARSHEIM
- 1998SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019217 · ICU MEDICAL INC
- 1992SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 020178 · BAXTER HLTHCARE
- 1992BRONCHO SALINEBrand (NDA)
NDA 019912 · BLAIREX
- 1988SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 019759 · HOSPIRA
- 1988SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBrand (NDA)
NDA 019635 · B BRAUN
- 1987SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINERBrand (NDA)
NDA 019329 · ABRAXIS PHARM
- 1985SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 016677 · BAXTER HLTHCARE
- 1985SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019480 · HOSPIRA
- 1985SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019465 · HOSPIRA
- 1985SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINERBrand (NDA)
NDA 019319 · BAXTER HLTHCARE
- 1984SODIUM CHLORIDE 14.6%Brand (NDA)
NDA 018897 · HOSPIRA
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.

