sterile water

Generic: water

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

Drug Facts

Product Profile

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

water 1 mL/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6147
Product ID 0641-6147_081540ac-58cf-437f-ba1b-86d5264ec3dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206369
Listing Expiration 2026-12-31
Marketing Start 2015-09-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416147
Hyphenated Format 0641-6147

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 water (source: ndc)
Application Number ANDA206369 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mL/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6147-10) / 10 mL in 1 VIAL (0641-6147-01)
  • 25 VIAL in 1 CARTON (0641-6147-25) / 10 mL in 1 VIAL (0641-6147-01)
source: ndc

Packages (2)

0641-6147-10 10 VIAL in 1 CARTON (0641-6147-10) / 10 mL in 1 VIAL (0641-6147-01) 0641-6147-25 25 VIAL in 1 CARTON (0641-6147-25) / 10 mL in 1 VIAL (0641-6147-01)

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": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "081540ac-58cf-437f-ba1b-86d5264ec3dc", "openfda": {"unii": ["059QF0KO0R"], "spl_set_id": ["78ef7ad3-451d-43d0-a9b6-5cf0aadca003"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6147-10)  / 10 mL in 1 VIAL (0641-6147-01)", "package_ndc": "0641-6147-10", "marketing_start_date": "20150903"}, {"sample": false, "description": "25 VIAL in 1 CARTON (0641-6147-25)  / 10 mL in 1 VIAL (0641-6147-01)", "package_ndc": "0641-6147-25", "marketing_start_date": "20150903"}], "brand_name": "Sterile Water", "product_id": "0641-6147_081540ac-58cf-437f-ba1b-86d5264ec3dc", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0641-6147", "generic_name": "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": "ANDA206369", "marketing_category": "ANDA", "marketing_start_date": "20150903", "listing_expiration_date": "20261231"}