sterile water

Generic: sterile water

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

Drug Facts

Product Profile

Brand Name sterile water
Generic Name sterile water
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

water 1 mL/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9339
Product ID 0143-9339_2558c762-cdc9-4135-a83e-8d4c5c9d1afc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212735
Listing Expiration 2026-12-31
Marketing Start 2023-05-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439339
Hyphenated Format 0143-9339

Supplemental Identifiers

UNII
059QF0KO0R

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 sterile water (source: ndc)
Generic Name sterile water (source: ndc)
Application Number ANDA212735 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mL/mL
source: ndc
Packaging
  • 12 BAG in 1 CASE (0143-9339-12) / 1000 mL in 1 BAG
source: ndc

Packages (1)

0143-9339-12 12 BAG in 1 CASE (0143-9339-12) / 1000 mL in 1 BAG

Ingredients (1)

water (1 mL/mL)

Linked Drug Pages (1)

Sterile Water ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2558c762-cdc9-4135-a83e-8d4c5c9d1afc", "openfda": {"unii": ["059QF0KO0R"], "spl_set_id": ["b20a28b0-7dfa-42eb-9177-ec256d5a5ef7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CASE (0143-9339-12)  / 1000 mL in 1 BAG", "package_ndc": "0143-9339-12", "marketing_start_date": "20230505"}], "brand_name": "Sterile Water", "product_id": "0143-9339_2558c762-cdc9-4135-a83e-8d4c5c9d1afc", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0143-9339", "generic_name": "Sterile Water", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sterile Water", "active_ingredients": [{"name": "WATER", "strength": "1 mL/mL"}], "application_number": "ANDA212735", "marketing_category": "ANDA", "marketing_start_date": "20230505", "listing_expiration_date": "20261231"}