Assyro AI

FDA Orange Book · active-ingredient family

Sodium chloride

Sodium chloride is approved as 36 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SODIUM CHLORIDE 0.9% · NDA 202832

36

Brand (NDA)

20

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, metered, injectable, solution, solution for slush

ProductApplicantApplicationTEApproved
SODIUM CHLORIDE 0.9%RLD×6MEDEFIL INCNDA 202832—Jan 06, 2012
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×2LIEBEL-FLARSHEIMNDA 021569—Jul 27, 2006
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×4ICU MEDICAL INCNDA 019217—Nov 18, 1998
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×2BAXTER HLTHCARENDA 020178APDec 07, 1992
BRONCHO SALINERLDBLAIREXNDA 019912—Sep 03, 1992
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERRLD×5B BRAUNNDA 019635APMar 09, 1988
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINERRLDABRAXIS PHARMNDA 019329—Apr 22, 1987
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×3BAXTER HLTHCARENDA 016677—Oct 30, 1985
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDHOSPIRANDA 019480APSep 17, 1985
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×2HOSPIRANDA 019465APJul 15, 1985
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINERRLDBAXTER HLTHCARENDA 019319—May 17, 1985
SODIUM CHLORIDE 14.6%RLD×3HOSPIRANDA 018897—Jul 20, 1984
SODIUM CHLORIDE 3% IN PLASTIC CONTAINERRLD×2BAXTER HLTHCARENDA 019022APNov 01, 1983
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×3HOSPIRANDA 018800APOct 29, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×6HOSPIRANDA 018803APOct 29, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERRLDBAXTER HLTHCARENDA 018016APApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 018090APApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDB BRAUNNDA 017464APApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 016366APApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDB BRAUNNDA 016733ATApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 017514ATApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHOSPIRANDA 019759APJun 08, 1988
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2ABBOTTNDA 019218—Jul 13, 1984
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 018497—Feb 19, 1982
SODIUM CHLORIDEABBOTTNDA 017013—Approved Prior to Jan 1, 1982
SODIUM CHLORIDEB BRAUNNDA 017038—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERB BRAUNNDA 018184—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERMILESNDA 018503—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2MILESNDA 018502—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 017864—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHOSPIRANDA 017670—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHOSPIRANDA 018380—Approved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 017427ATApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 017867ATApproved Prior to Jan 1, 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEROTSUKA ICU MEDCLNDA 018314ATApproved Prior to Jan 1, 1982
SODIUM CHLORIDE IN PLASTIC CONTAINERMILESNDA 018247—Approved Prior to Jan 1, 1982

Generic (ANDA) products (20)

ProductApplicantApplicationTEApproved
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFRESENIUS KABI USAANDA 213688ATJun 24, 2024
SODIUM CHLORIDE 0.9%×2NEXUSANDA 217535APAug 23, 2023
SODIUM CHLORIDE 23.4%FRESENIUS KABI USAANDA 217796APJul 11, 2023
SODIUM CHLORIDE 23.4%FRESENIUS KABI USAANDA 212248APApr 28, 2021
SODIUM CHLORIDE 14.6%×3FRESENIUS KABI USAANDA 212070—Apr 28, 2021
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2NEPHRONANDA 211968APApr 23, 2020
SODIUM CHLORIDE 3% IN PLASTIC CONTAINERFRESENIUS KABI USAANDA 209476APMar 13, 2019
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERFRESENIUS KABI USAANDA 208122APJul 23, 2018
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFRESENIUS KABI USAANDA 207310APSep 19, 2017
SODIUM CHLORIDE 0.9%×2SPECTRA MDCL DEVICESANDA 206171APJul 21, 2017
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERLABORATORIOS GRIFOLSANDA 207956APMay 25, 2017
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2JUBILANT CADISTAANDA 203352—May 18, 2016
SODIUM CHLORIDE 0.9%×2HIKMAANDA 201833—Sep 24, 2013
SODIUM CHLORIDE 0.9%HIKMAANDA 201850—Jan 20, 2012
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFRESENIUS MEDCLANDA 078177APApr 12, 2007
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2TAROANDA 077407APAug 11, 2006
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGVS TMANDA 076316APOct 27, 2004
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×4FRESENIUS KABI USAANDA 088912—Nov 29, 1985
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2FRESENIUS KABI USAANDA 088911APMay 17, 1985
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2ABRAXIS PHARMANDA 088909—May 15, 1985

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.

Sodium chloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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