NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9971Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9971Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0404-9971-0000404997100004049971001 VIAL, GLASS in 1 BAG (0404-9971-00) / 100 mL in 1 VIAL, GLASSMarketed from Jan 10, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Sterile Water
Generic name (nonproprietary)
water
Active ingredients
Water — 1 mL/mL
Dosage form
Injection
Route
Intramuscular, Intravenous, Subcutaneous
Labeler
Henry Schein, Inc.NDC labeler code 0404
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 018801
Marketing start
Listing expires
Identifiers
Product ID 0404-9971_89dfebe4-a611-4fbb-9e79-b4b2ac6311cdSPL ID 89dfebe4-a611-4fbb-9e79-b4b2ac6311cdSPL set ID f4087143-9868-4308-b96c-43657ee8ec28UNII 059QF0KO0R

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400404997100 followed by a unit qualifier and the quantity

Package 00404-9971-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9971

What is NDC 0404-9971?
0404-9971 is the product NDC for Sterile Water (water), Water 1 mL/mL injection, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sterile Water (Water).
What is the active ingredient?
Water.
Who is the labeler?
Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sterile Water?
42 other product NDCs are listed under this name. See all Sterile Water NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sterile Water NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousREMEDYREPACK INC.70518-473270518-4732-01
Sterile WaterwaterWater 1 mL/mLInjectionIrrigationFresenius Kabi USA, LLC65219-49565219-0495-10
Sterile WaterwaterWater 1 mL/mLInjectionIrrigationFresenius Kabi USA, LLC65219-49765219-0497-20
Sterile WaterwaterWater 1 mL/mLInjectionIrrigationBecton Dickinson and Company17271-80217271-0802-0717271-0802-0817271-0802-09
Sterile Waterwater injectionWater 1 mL/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHenry Schein, Inc.0404-978100404-9781-10
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-002400409-0024-10
Sterile WaterwaterWater 1 mL/mLInjectionIrrigationFresenius Kabi USA, LLC65219-49965219-0499-30
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousCardinal Health 107, LLC55154-958855154-9588-05
Sterile WaterWater 1 mL/mLInjection, SolutionIntravenousHikma Pharmaceuticals USA Inc.0143-933900143-9339-12
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousFresenius Kabi USA, LLC65219-18765219-0187-10

All 43 Sterile Water NDCs

Other NDCs under NDA 018801

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 018801
ProductStrengthForm · routeLabelerProduct NDC
Sterile WaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co. LLC, DBA HealthFirst51662-1266
Sterile WaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1329
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousA-S Medication Solutions50090-2874
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousMedical Purchasing Solutions, LLC71872-7290
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-4887
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousProPharma Distribution84549-887
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousAsclemed USA, Inc.76420-082
Sterile WaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1474
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-0024
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousREMEDYREPACK INC.70518-4732
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHenry Schein, Inc.0404-9959
Sterile WaterwaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousCardinal Health 107, LLC55154-0127
Sterile WaterWater 1 mL/mLInjectionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1265

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