sodium chloride

Generic: sodium chloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium chloride
Generic Name sodium chloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

sodium chloride 9 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-0497
Product ID 0641-0497_0950e98d-bfec-40e8-9f56-ba90e0d6e8c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201833
Listing Expiration 2026-12-31
Marketing Start 2013-09-24

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 06410497
Hyphenated Format 0641-0497

Supplemental Identifiers

RxCUI
1807636 1807637
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 ANDA201833 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 9 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-0497-25) / 2 mL in 1 VIAL (0641-0497-17)
source: ndc

Packages (1)

0641-0497-25 25 VIAL in 1 CARTON (0641-0497-25) / 2 mL in 1 VIAL (0641-0497-17)

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": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "0950e98d-bfec-40e8-9f56-ba90e0d6e8c8", "openfda": {"unii": ["451W47IQ8X"], "rxcui": ["1807636", "1807637"], "spl_set_id": ["e5ee8caa-b6ca-45ba-98fb-8305e6282141"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-0497-25)  / 2 mL in 1 VIAL (0641-0497-17)", "package_ndc": "0641-0497-25", "marketing_start_date": "20130924"}], "brand_name": "Sodium Chloride", "product_id": "0641-0497_0950e98d-bfec-40e8-9f56-ba90e0d6e8c8", "dosage_form": "INJECTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]"], "product_ndc": "0641-0497", "generic_name": "Sodium Chloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Chloride", "active_ingredients": [{"name": "SODIUM CHLORIDE", "strength": "9 mg/mL"}], "application_number": "ANDA201833", "marketing_category": "ANDA", "marketing_start_date": "20130924", "listing_expiration_date": "20261231"}