sodium acetate

Generic: sodium acetate

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

Drug Facts

Product Profile

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

sodium acetate anhydrous 164 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6263
Product ID 0641-6263_777b7564-f07b-401a-a042-0cd512ae3b25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216920
Listing Expiration 2026-12-31
Marketing Start 2024-05-20

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 06416263
Hyphenated Format 0641-6263

Supplemental Identifiers

RxCUI
237371
UNII
NVG71ZZ7P0

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 acetate (source: ndc)
Generic Name sodium acetate (source: ndc)
Application Number ANDA216920 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 164 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6263-10) / 100 mL in 1 VIAL (0641-6263-01)
source: ndc

Packages (1)

0641-6263-10 10 VIAL in 1 CARTON (0641-6263-10) / 100 mL in 1 VIAL (0641-6263-01)

Ingredients (1)

sodium acetate anhydrous (164 mg/mL)

Linked Drug Pages (1)

Sodium Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "777b7564-f07b-401a-a042-0cd512ae3b25", "openfda": {"unii": ["NVG71ZZ7P0"], "rxcui": ["237371"], "spl_set_id": ["7ee23a1c-bc99-4ff6-b2e7-d2aa42744553"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6263-10)  / 100 mL in 1 VIAL (0641-6263-01)", "package_ndc": "0641-6263-10", "marketing_start_date": "20240520"}], "brand_name": "Sodium Acetate", "product_id": "0641-6263_777b7564-f07b-401a-a042-0cd512ae3b25", "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": "0641-6263", "generic_name": "Sodium Acetate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Acetate", "active_ingredients": [{"name": "SODIUM ACETATE ANHYDROUS", "strength": "164 mg/mL"}], "application_number": "ANDA216920", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}