sterile water

Generic: sterile water for injection

Labeler: medefil, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sterile water
Generic Name sterile water for injection
Labeler medefil, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

water 100 mL/100mL

Manufacturer
Medefil, Inc.

Identifiers & Regulatory

Product NDC 64253-020
Product ID 64253-020_2b39b41d-419a-dab8-e063-6394a90a319a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211188
Listing Expiration 2026-12-31
Marketing Start 2020-01-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64253020
Hyphenated Format 64253-020

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 for injection (source: ndc)
Application Number ANDA211188 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mL/100mL
source: ndc
Packaging
  • 60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTIC
  • 60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC
  • 60 SYRINGE, PLASTIC in 1 BOX (64253-020-25) / 5 mL in 1 SYRINGE, PLASTIC
  • 60 SYRINGE, PLASTIC in 1 BOX (64253-020-30) / 10 mL in 1 SYRINGE, PLASTIC
  • 60 SYRINGE, PLASTIC in 1 BOX (64253-020-35) / 5 mL in 1 SYRINGE, PLASTIC
  • 60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTIC
  • 10 SYRINGE, PLASTIC in 1 BOX (64253-020-91) / 10 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (7)

64253-020-21 60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTIC 64253-020-23 60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC 64253-020-25 60 SYRINGE, PLASTIC in 1 BOX (64253-020-25) / 5 mL in 1 SYRINGE, PLASTIC 64253-020-30 60 SYRINGE, PLASTIC in 1 BOX (64253-020-30) / 10 mL in 1 SYRINGE, PLASTIC 64253-020-35 60 SYRINGE, PLASTIC in 1 BOX (64253-020-35) / 5 mL in 1 SYRINGE, PLASTIC 64253-020-52 60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTIC 64253-020-91 10 SYRINGE, PLASTIC in 1 BOX (64253-020-91) / 10 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

water (100 mL/100mL)

Linked Drug Pages (1)

Sterile Water ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "2b39b41d-419a-dab8-e063-6394a90a319a", "openfda": {"unii": ["059QF0KO0R"], "spl_set_id": ["99e99a50-82d5-aff6-e053-2a95a90a8c56"], "manufacturer_name": ["Medefil, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-21)  / 1 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-21", "marketing_start_date": "20200127"}, {"sample": false, "description": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-23)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-23", "marketing_start_date": "20200127"}, {"sample": false, "description": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-25)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-25", "marketing_start_date": "20200921"}, {"sample": false, "description": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-30)  / 10 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-30", "marketing_start_date": "20200127"}, {"sample": false, "description": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-35)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-35", "marketing_start_date": "20200127"}, {"sample": false, "description": "60 SYRINGE, PLASTIC in 1 BOX (64253-020-52)  / 2.5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-52", "marketing_start_date": "20200127"}, {"sample": false, "description": "10 SYRINGE, PLASTIC in 1 BOX (64253-020-91)  / 10 mL in 1 SYRINGE, PLASTIC", "package_ndc": "64253-020-91", "marketing_start_date": "20200921"}], "brand_name": "Sterile Water", "product_id": "64253-020_2b39b41d-419a-dab8-e063-6394a90a319a", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "64253-020", "generic_name": "Sterile Water for Injection", "labeler_name": "Medefil, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sterile Water", "active_ingredients": [{"name": "WATER", "strength": "100 mL/100mL"}], "application_number": "ANDA211188", "marketing_category": "ANDA", "marketing_start_date": "20200127", "listing_expiration_date": "20261231"}