NDC codes

FDA NDC Directory
Product NDC (as listed)83243-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83243-0001Add 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
83243-001-01832430001013 APPLICATOR in 1 PACKAGE (83243-001-01) / .5 mL in 1 APPLICATORMarketed from Feb 13, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Azzurx
Generic name (nonproprietary)
melissa officinalis leaf,thuja occidentalis leaf,geranium maculatum,calendula officinalls
Active ingredients
Melissa officinalis leaf — 3 [hp_X]/.5mLThuja occidentalis leaf — 3 [hp_X]/.5mLGeranium maculatum root — 3 [hp_X]/.5mLCalendula officinalis flower — 3 [hp_X]/.5mL
Dosage form
Liquid
Route
Topical
Labeler
Outbreaks, Inc.NDC labeler code 83243
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 83243-001_29f05aaf-89b2-e293-e063-6394a90ad0e5SPL ID 29f05aaf-89b2-e293-e063-6394a90ad0e5SPL set ID 9e48aaac-48c2-451d-9f6f-369e65c1c52bUNII 50D2ZE9219, 0T0DQN8786, 93IXI5B6OJ, P0M7O4Y7YD

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

N483243000101 followed by a unit qualifier and the quantity

Package 83243-0001-01. 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 For treatment of cold sores and fever blisters.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83243-001

What is NDC 83243-001?
83243-001 is the product NDC for Azzurx, Melissa officinalis leaf 3 [hp_X]/.5mL + 3 more ingredients liquid, listed with the FDA by Outbreaks, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Azzurx (MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALlS).
What is the active ingredient?
Melissa officinalis leaf, Thuja occidentalis leaf, Geranium maculatum root, Calendula officinalis flower.
Who is the labeler?
Outbreaks, Inc., NDC labeler code 83243. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azzurx?
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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