sodium chloride

Generic: sodium chloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium chloride
Generic Name sodium chloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sodium chloride 9 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-282
Product ID 65219-282_2ad355c8-4420-42d5-8ea8-b4cc3ccc1c0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207310
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219282
Hyphenated Format 65219-282

Supplemental Identifiers

RxCUI
1807639
UNII
451W47IQ8X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sodium chloride (source: ndc)
Generic Name sodium chloride (source: ndc)
Application Number ANDA207310 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 9 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CASE (65219-282-10) / 1000 mL in 1 BAG (65219-282-01)
source: ndc

Packages (1)

65219-282-10 10 BAG in 1 CASE (65219-282-10) / 1000 mL in 1 BAG (65219-282-01)

Ingredients (1)

sodium chloride (9 mg/mL)

Linked Drug Pages (1)

Sodium chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2ad355c8-4420-42d5-8ea8-b4cc3ccc1c0e", "openfda": {"unii": ["451W47IQ8X"], "rxcui": ["1807639"], "spl_set_id": ["6d43fa91-0940-437f-ba70-b2d3f977593e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CASE (65219-282-10)  / 1000 mL in 1 BAG (65219-282-01)", "package_ndc": "65219-282-10", "marketing_start_date": "20230630"}], "brand_name": "Sodium chloride", "product_id": "65219-282_2ad355c8-4420-42d5-8ea8-b4cc3ccc1c0e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]"], "product_ndc": "65219-282", "generic_name": "SODIUM CHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium chloride", "active_ingredients": [{"name": "SODIUM CHLORIDE", "strength": "9 mg/mL"}], "application_number": "ANDA207310", "marketing_category": "ANDA", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}