sterile water
Generic: water
Labeler: baxter healthcare corporationDrug Facts
Product Profile
Brand Name
sterile water
Generic Name
water
Labeler
baxter healthcare corporation
Dosage Form
IRRIGANT
Routes
Active Ingredients
water 100 mL/100mL
Manufacturer
Identifiers & Regulatory
Product NDC
0338-0004
Product ID
0338-0004_43dc7530-ed0a-4976-af2a-0d39a2532fb7
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA017428
Listing Expiration
2026-12-31
Marketing Start
1974-12-31
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
03380004
Hyphenated Format
0338-0004
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
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
NDA017428 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 100 mL/100mL
Packaging
- 24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC
- 18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC
- 12 BOTTLE, PLASTIC in 1 CARTON (0338-0004-04) / 1000 mL in 1 BOTTLE, PLASTIC
Packages (3)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["IRRIGATION"], "spl_id": "43dc7530-ed0a-4976-af2a-0d39a2532fb7", "openfda": {"unii": ["059QF0KO0R"], "rxcui": ["150985"], "spl_set_id": ["ef3e79c5-3f58-4b36-a296-64b7d9a651c1"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0338-0004-02", "marketing_start_date": "19741231"}, {"sample": false, "description": "18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0338-0004-03", "marketing_start_date": "19741231"}, {"sample": false, "description": "12 BOTTLE, PLASTIC in 1 CARTON (0338-0004-04) / 1000 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0338-0004-04", "marketing_start_date": "19741231"}], "brand_name": "Sterile Water", "product_id": "0338-0004_43dc7530-ed0a-4976-af2a-0d39a2532fb7", "dosage_form": "IRRIGANT", "product_ndc": "0338-0004", "generic_name": "Water", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sterile Water", "active_ingredients": [{"name": "WATER", "strength": "100 mL/100mL"}], "application_number": "NDA017428", "marketing_category": "NDA", "marketing_start_date": "19741231", "listing_expiration_date": "20261231"}