NDC codes

FDA NDC Directory
Product NDC (as listed)0264-2101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00264-2101Add 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
0264-2101-00002642101000026421010016 CONTAINER in 1 CASE (0264-2101-00) / 1000 mL in 1 CONTAINERMarketed from Sep 10, 1970
0264-2101-10002642101100026421011016 CONTAINER in 1 CASE (0264-2101-10) / 500 mL in 1 CONTAINERMarketed from Sep 10, 1970

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
Irrigant
Route
Irrigation
Labeler
B. Braun Medical Inc.NDC labeler code 0264
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 016734
Marketing start
Listing expires
Identifiers
Product ID 0264-2101_17177669-a426-414d-b0b8-ec70dad03197SPL ID 17177669-a426-414d-b0b8-ec70dad03197

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.

NDC on a medical claim

N400264210100 followed by a unit qualifier and the quantity

Package 00264-2101-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0264-2101

What is NDC 0264-2101?
0264-2101 is the product NDC for Sterile Water (water), Water 1 mL/mL irrigant, listed with the FDA by B. Braun Medical Inc.. It has 2 package NDCs, 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?
B. Braun Medical Inc., NDC labeler code 0264. 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?
43 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 44 Sterile Water NDCs

Other NDCs under NDA 016734

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

FDA NDC Directory listings under NDA 016734
ProductStrengthForm · routeLabelerProduct NDC
Sterile WaterWater 100 mL/100mLIrrigantIrrigationB. Braun Medical Inc.0264-7386

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