NDC codes

FDA NDC Directory
Product NDC (as listed)0116-1060Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00116-1060Add 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
0116-1060-320011610603200116106032946 mL in 1 BOTTLE, PLASTIC (0116-1060-32)Marketed from Nov 15, 2023
0116-1060-330011610603300116106033946 mL in 1 BOTTLE, PLASTIC (0116-1060-33)Marketed from Dec 14, 2023

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)
Dyna-Hex 4
Generic name (nonproprietary)
chlorhexidine gluconate
Active ingredients
Chlorhexidine gluconate — 4 g/100mL
Dosage form
Liquid
Route
Topical
Labeler
Xttrium Laboratories, Inc.NDC labeler code 0116
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019127
Marketing start
Listing expires
Other FDA classes
Decreased Cell Wall Integrity (Physiologic effect)
Identifiers
Product ID 0116-1060_50b0c122-cb50-3a71-e063-6294a90a5497SPL ID 50b0c122-cb50-3a71-e063-6294a90a5497SPL set ID 0a32c299-f7ca-d15c-e063-6294a90af2c1RxCUI 211365, 834162UNII MOR84MUD8EUPC 0301161060330

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400116106032 followed by a unit qualifier and the quantity

Package 00116-1060-32. 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)

Uses  surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care  healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0116-1060

What is NDC 0116-1060?
0116-1060 is the product NDC for Dyna-Hex 4 (chlorhexidine gluconate), Chlorhexidine gluconate 4 g/100mL liquid, listed with the FDA by Xttrium Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dyna-Hex 4 (Chlorhexidine Gluconate).
What is the active ingredient?
Chlorhexidine gluconate.
Who is the labeler?
Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dyna-Hex 4?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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