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SODIUM CHLORIDE 0.9%

ANDA

SODIUM CHLORIDE | A201833 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 Orange Book Listing of Sodium Chloride 0.9% Irrigation USP re Su... FDA-2019-P-6048 · 5 docket documents Fresenius Kabi USA, LLC filed a petition regarding the Orange Book listing of Sodium Chloride 0.9% Irrigation USP, challenging its suitability classification and requesting that the FDA reconsider or modify the regulatory status of this irrigation solution product in the Orange Book.	Suitability	2019-12-26	Open	Fresenius Kabi USA, LLC
Citizen Petition from Beckloff Associates FDA-2006-P-0084 · 6 docket documents Beckloff Associates filed a citizen petition regarding Hospira's Sodium Chloride 0.9% in Plastic Container (NDA 419217), an injectable solution approved on July 13, 1984, though the specific regulatory action requested is not detailed in the provided documentation excerpt.	Other	2009-03-18	Granted	Beckloff Associates

Source: Regulations.gov. FDA citizen petitions matched by application number.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$20.10

Highest Price

$20.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00641-0497-25SODIUM CHLORIDE 0.9% (PF) INJ	$20.10	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

MARIAGER SALT SPECIALTIES A/SSODIUM CHLORIDE

DMF 221912010

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE BP (PARENTERAL GRADE)

DMF 231052009

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE USP

DMF 284732014

VM CHEMICALSSODIUM CHLORIDE BP

DMF 290372015

EMNAR PHARMA PRIVATE LTDSODIUM CHLORIDE

DMF 414192025

CAMBRIDGE NUCLEAR RADIOPHARM CORPInactiveSODIUM CHLORIDE NA-24

DMF 22861974

ARES SERONO SAInactiveSODIUM CHLORIDE FOR INJECTION

DMF 100301993

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL

DMF 156592001

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION USP 0.9%

DMF 215442008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 18MG/2ML (9MG/ML)

0 patents0 exclusivities▴

SOLUTION;INJECTION | Approved: Sep 24, 2013

No patent or exclusivity listings for this strength.

#002 — 90MG/10ML (9MG/ML)

0 patents0 exclusivities▾

SOLUTION;INJECTION | Approved: Jan 7, 2015