NDC codes

FDA NDC Directory
Product NDC (as listed)10819-1080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10819-1080Add 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
10819-1080-2108191080023000 POUCH in 1 CASE (10819-1080-2) / 1 mL in 1 POUCHMarketed from Jan 15, 2013

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Prevantics Swab
Generic name (nonproprietary)
chlorhexidine gluconate and isopropyl alcohol
Active ingredients
Chlorhexidine gluconate — 31.5 mg/mLIsopropyl alcohol — .7 mL/mL
Dosage form
Solution
Route
Topical
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021524
Marketing start
Listing expires
Other FDA classes
Decreased Cell Wall Integrity (Physiologic effect)
Identifiers
Product ID 10819-1080_078de79b-c16c-78f8-e063-6294a90a384aSPL ID 078de79b-c16c-78f8-e063-6294a90a384aSPL set ID ff999b50-0b6b-404e-b4f1-c6694fe47a9bRxCUI 1191171, 1366736UNII MOR84MUD8E, ND2M416302

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

N410819108002 followed by a unit qualifier and the quantity

Package 10819-1080-02. 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)

Use for the preparation of the patient's skin prior to an injection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021524

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

FDA NDC Directory listings under NDA 021524
ProductStrengthForm · routeLabelerProduct NDC
Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholChlorhexidine gluconate 31.5 mg/mL; Isopropyl alcohol .7 mL/mLSolutionTopicalProfessional Disposables International, Inc.10819-4076
Prevantics Swabstickchlorhexidine gluconate and isopropyl alcoholChlorhexidine gluconate 31.5 mg/mL; Isopropyl alcohol .7 mL/mLSolutionTopicalProfessional Disposables International, Inc.10819-4077

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